Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220753
Status:
COMPLETED
Last Update Posted:
2009-07-23
First Post:
2005-09-19
Brief Title:
Air Cleaners for Children and Adolescents With Asthma and Dog Allergy
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
Official Title:
Air Cleaners for Children and Adolescents With Asthma and Dog Allergy
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose is to find out if Icleen IQAir HEPA-filter air cleaners with high capacity and pre-set speed functions have a beneficial effect on patients with asthma and allergy to dogs
Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry with allergy to dogs but not to house dust mites
The investigators will look upon the significance of this study and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader or makes it likely that the seemingly beneficial effects of the first study occurred by chance
Main parameters
hyperventilation cold air challenge test
Supportive parameters
serum ECP
symptom scores
The trial will be a parallel double blind placebo controlled one
Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry with allergy to dogs but not to house dust mites
The investigators will look upon the significance of this study and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader or makes it likely that the seemingly beneficial effects of the first study occurred by chance
Main parameters
hyperventilation cold air challenge test
Supportive parameters
serum ECP
symptom scores
The trial will be a parallel double blind placebo controlled one
Detailed Description:
Project leader Leif Bjarte Rolfsjord MD section leader Paediatric Department Sykehuset Innlandet HF Elverum-Hamar Ragnhild Halvorsen MD PhD Voksentoppen Paediatric Clinic Rikshospitalet Leiv Sandvik PhD professor research leader statistics Competence Centre for Clinical Research Ullevaal University Hospital
AIM
To examine if powerful air cleaners with HEPA-filters and a pre-set speed function making it possible to run the air cleaners at a high but noisy speed at acceptable times and if wanted at a lower but less noisy speed at other times Icleen IQAir have a favourable effect on asthma in children and adolescents aged 8-17 years who are allergic to dogs but not to house dust mite To look at this study separately but also look upon the total results of this study and a previous study performed by the project leader
BACKGROUND
The first study is not yet published We found signs of clinically significant effects of active air cleaners by the parameters ECP in serum and bronchial hyperreactivity by a cold air hyperventilation test but the results gave p-values at the border of statistical significance p0104 for FEV1 reduction and significant results p0018 for differences in the change of ECP The number of patients included in the study was 49 a lower number than wanted in the first place We did not find significant effects on Liz Junipers Life Quality Scale scores Yet there are reasons to believe that the results of the first study may have clinical significance A cold air hyperventilation test reflects a real life situation in interior parts of Norway resembling outdoor winter conditions strongly In the first study Allergy Control encasing over pillows eiderdowns and mattresses were applied compared to placebo but no signs of effects were found on these children aged 7 to 17 with allergy to dog or cat but not to house dust mites The reason to exclude house dust mite allergic patients in the first trial was to examine if encasings could have any effect on patients without house dust mite allergy and the fact that house dust mite allergy is less common in Northern interior areas where the trial took place Other studies indicate however that air cleaners can reduce allergens from dogs and cats but not most other indoor allergens 3 We want to perform a new trial and publish the results from each trial in one publication but also look upon the results of a meta-analysis of both studies Our hope is that the two trials can give more reliable information about the effects of the air cleaners This time no dust analyses will be taken because dust analyses from the first trial sent to dr Susanne Lau at the Charité-Virchow Clinic in Berlin showed that the air cleaners removed considerable amounts of dust personal message from dr Lau The results have been summarised in an article by Groth C et al in Allergy in 2002 and a manuscript for an article is now sent to Allergy for publication The efficiency of IQAir air cleaners has also been documented by Stiftung Warentest in Germany Due to limited resources and the signs of low sensitivity in such a trial Liz Junipers Life Quality Scale will not be applied this time For economic reasons hair samples for nicotine analysis will not be taken this time
Since the first trial was completed an important improvement of the air cleaners has arisen A new panel makes it possible to pre-set the air cleaners at different speeds or on and off at different times of the day at different days of the week Once a day the speed can be changed to another speed or turned off and once a day it can be turned back to the original speed in advance In addition the pre-set function can be overridden manually at any time In the first trial the timer on and off function could turn the air cleaners off once a day and on once a day with no active cleaning during the timer off intervals and no weekday differentiation of the timer This improvement increases the likelihood that the air cleaners will be used at higher and more noisy speeds at times when nobody is at home resulting in lower levels of flying allergen dust levels even at times when people are at home
In the first trial we did not find significantly stronger effects in homes with animals than in homes without animals Only a fourth of the homes had animals through the whole trial period For this reason we will only include homes without pets this time in order to get a more homogenous population In the first trial we had a lower age limit of 7 This time the lower age limit is 8 to make it easier for patients to co-operate avoiding frustration for seven-year-olds who may be excluded due to co-operation difficulties The reason that we require dog allergy this time not dog or cat allergy as in the first trial is that one trial indicates that air cleaners only reduce the amount of airborne cat allergens marginally if no cat is in the room This trial was performed in homes with cats 5 On the other hand a trial of effects of air cleaners in homes with dogs showed a significant reduction of dog allergens even in rooms where dogs were not present 1 The studies are difficult to compare however because different dust sampling methods were applied
MATERIAL
30 patients from Hedmark county in south-eastern Norway will be examined for the study at the start The patients will be selected from journals of patients having visited the hospital for asthma during the previous three years having had verified allergy against dog but not house dust mite
TRIAL DESIGN
1 Active group IQAir air cleaners one in the patients bedroom and one in the room mostly used by the patient outside the bedroom with real pre- and main filters
2 Placebo group As above but the main filter substituted by a placebo filter If the parents of the child do not live together and the child visits the other parent at least every second weekend both parents will be supplied with air cleaners of the same type with equivalent placing of the cleaners
The air cleaners are labelled either A or B indicating if they are real or fake Until closing of the trial only the manufacturer will know the code The patients will be randomised either to A or B with no stratification The air cleaners are sealed Hence it is not possible to open them to see what kind of filters they have without breaking the seal Even the placebo filters will seem real for people not accustomed to looking inside air cleaners
Protocol attachments
Skin prick tests and specific IgE will only be performed at visit 1 Other examinations and questions applied at both visits
ATTACHMENT 1 Clinical examination
Height weight inspection of thorax any stridor must be recorded respiration frequency lung auscultation The signs recorded after the Kjell Aas scale from P0 to P6
P0 Normal P1 No discomfort Slightly weakened auscultatory ventilation sound P2 No discomfort A few sibili fine wheezing sounds or rhonchi at auscultation Prolonged audible expirium No retractions
P3 No discomfort at rest Abundant obstructive sounds Slight jugular retraction some use of auxiliary ventilation muscles Possibly elevated shoulders
P4 Some discomfort at rest Abundant obstructive sounds Fine wheezing heard without stethoscope Jugularintercostal retractions Use of auxiliary ventilation muscles Worse P5 after cough
P5 Considerable discomfort at rest Abundant obstructive sounds Wheezing expiration Wheezing without stethoscope Energetic use of auxiliary ventilation muscles Possibly slight cyanosis
P6 Alarming obstruction Often even inspiratory obstruction NB Weak respiratory sounds but retractions and use of auxiliary muscles and tachypnoea are especially alarming Possible cyanosis
ATTACHMENT 2 Cold air provocation test - method Material
1 Rhes-pro cold air unit delivering cold air with a 52 CO2 content to avoid hypocapnia at hyperventilation The apparatus must be calibrated to give a standardised temperature -15C of the inhaled air at lip level and 52 CO2
2 Flow volume spirometer with computer
3 Before the test one must make sure that there is enough air and CO2 for the unit
Medication
Drugs that can affect the results must be avoided at a certain interval In our study the following drugs are withheld at the indicated intervals before the test
Short acting beta-2-agonist 12 hours
Long acting beta-2-agonist 24 hours
Beta-2-agonist slow release oral drugs Generally not used in our clinic If yet taken 3 days
Theophylline slow release oral drugs Generally not used in our clinic If yet taken 3 days
Antihistamines 7 days
Leukotriene antagonists 48 hours
Atropine derivatives ipratropium bromide 8 hours After the test the patient can be given the rest of his ordinary morning drugs
Time of the day
1 The test should be performed at the same time every time preferably in the morning
2 The patient should rest for 15 minutes before the test to avoid influence by physical exercise bicycling running up stairs etc
Test method
1 Tests performed on Mondays must be avoided to prevent influence by casual contacts and activities in the course of the weekend before the test
2 Travels including staying overnight away from the home for more than a week should be registered and the test should be performed more than one week after arriving home from holiday
3 The patient must have normal clinical signs P0 before the cold air provocation or the test must be postponed
4 Take flow volume test best FEV1 out of 3 attempts A printout of the best spirometry attempt must be stored in the research archive The flow volume tests shall be performed in a sitting position The patient must use a nose clip during spirometry and cold air provocation
5 Provided FEV1 is 70 of predicted the test is started If 70 it is postponed
6 The air mixture flow is calculated by the pre-provocation best FEV1 value by multiplying FEV1 by 20 for children less than 13 years of age at the first visit and by 26 for the adolescents more than 13 years of age at the first visit The patient remains sitting during the cold air provocation
7 The patient is instructed to breathe rapidly and deeply through the mouthpiece during the provocation which lasts for 4 minutes In practice the test is performed by letting the child breathe sufficiently to keep a connected balloon or ventilation bag halfway filled
8 Spirometry with FEV1 must be performed straight before and 2 minutes after provocation
9 MEF50 FEF50 at each spirometry being recorded as the spirometry giving the best FEV1 will be registered
10 Auscultation signs immediately before each series of three spirometry attempts and possible cough will be registered
11 After the post-provocation spirometry two minutes after the provocation salbutamol Ventolin 01mg meter dose inhaler by Volumatic will be given for reversibility test 2 puffs for patients weighing less than 45 kg and 4 puffs for patients weighing 45 kg and more one puff at a time 5 inhalations per puff New spirometry will be performed 5 minutes after giving Ventolin and FEV1 is registered again in absolute value and percentage of the first value before cold air provocation
12 Even if the risk for acute severe asthmatic symptoms is low a nebuliser for giving salbutamol and adrenaline for subcutaneous injection and equipment for intravenous administration of antiasthmatic drugs will be easily availableThe treatment scheme from the Norwegian Paediatric Associations acute therapy book will be applied Evaluation of the test results Percentage fall in FEV1 and FEF50 will be applied as a parameter of bronchial reactivity More than 10 fall in FEV1 after cold air or more than 10 rise in FEV1 after inhalation of Ventolin is considered significant
Printouts of the spirometry results will be saved Patient registration sheet cold air hyperventilation test Printouts from spirometry to be attached
The following data will be noted
Time of day hours minute Height cm Weight kg Assisted by nurse Assisted by doctor
Questions to be asked
Staying away from home for more than 2 weeks last month or during trial Staying overnight away from home last week Staying overnight for more than a week less than one week ago Inhaled drugs - Ventolin Serevent Flutide doses numbers of hours ago Other drugs route Dose x times a day Last dose number of hours ago
To be recorded from spirometry
Best FEV1 pre-test litres per minute Temperature at mouthpiece will be held at -15 C Air flow in cold unit litres per minute CO2 flow in cold unit litres per minute Number of minutes of provocation Number of pauses Patients performance will be recorded as good acceptable or unacceptable
The following values and signs noted before provocation 2 minutes after provocation and 5 minutes after Ventolin given in a spacer Volumatic
FEV1 FEV1 increase or decrease - of pre-test MEF50 MEF50 of first Aas score P0-P6 Cough Other signs or symptoms If other rescue medication is given than Ventolin in Volumatic it must be noted
ATTACHMENT 3 Inquiry about animal contact
1 Are there pets in the home
2 Did you react by nose symptoms sneezing cough or breathing difficulties the last time you were close to a dog without having taken drugs against asthma or allergy
3 What kind of pet do you have in the home
If animal removed the last half year how many months ago Animal now Number of animals Specify if you have cat dog rabbit hamster other furred pets budgerigar other birds fish other animals
4 Are you patient in contact with animals outside the home How often what kind of animal ATTACHMENT 4 Inquiry about smoking The staff fill in questions to patient if the patient or anybody else in the home smokes and if smoking in the home totals less than 10 10-20 or more than 20 cigarettes a day
ATTACHMENT 5 Questions about fitted carpets humidity vacuum cleaners mechanical ventilation systems
The following questions are asked by staff to parent or accompanying person what person will be recordedFilled in together with
1 Do you have fitted carpets
2 Do you have fitted carpets in the childs bedroom
3 Do you have fitted carpets in the living room
4 Do you have fitted carpets in other rooms
5 Do you think that you have more than 5 cm of dew or frost on the inside of the window of the childs bedroom
6 Is there any smell of mould in your house
7 Where in the house is there a smell of mould
8 Can you see mould or rotten patches in any room
9 If yes where can you see it
10 What kind of vacuum cleaner do you have
11 Is there except for ventilation over the kitchen stove any kind of mechanical ventilation or air filtration in the home ATTACHMENT 6 Symptom score The patients are asked to draw a circle around one of the numbers from 1 through 5 indicating the degree of symptoms 1 meaning no or never 5 meaning many times each night severe always cannot breathe through my nose or cannot breathe through my nose while sitting still respectively For patients taking antihistamines the nose symptoms are valid for the last 5 days Otherwise the questions are applicable to the last month
Questions to patients at Visit 1 SepOct-05
1 Do you wake up at night due to asthma
2 How is your asthma during daytime
3 Do you feel your asthma when you run
4 Is your nose stuffy at night To patients who have taken antihistaminic agents regularly for the last month this question will be asked instead Has your nose been stuffy in daytime for the last 5 days
5 Is your nose stuffy during daytime To patients who have taken antihistaminic agents regularly for the last month this question will be asked instead Has your nose been stuffy in daytime for the last 5 days Finally a question is asked about strong asthma attacks last 3 months Options for answers ar no once or several times
ATTACHMENT 7 Medication Prophylactic medication will be kept constant during the trial Doubling doses of inhaled steroids for maximum two weeks during exacerbations or airway infections or in patients not taking inhaled steroids daily taking inhaled steroids for maximum two weeks during exacerbations or airway infections will be accepted Systemic corticosteroids in the trial period will lead to exclusion
Ongoing medication See section about cold air challenge attachment 2
Pre-trial medication
Date prescribed or 1-3 between 1 and 3 months ago or 3 more than 3 months ago Drug name Total amount of doses prescribed Generic name Drug type tablets oral mixture injection liquid etc Administration route Amount per dose Measured as ml mg etc Times a day in good periods Times a day in bad periods or prodromal stages Max duration of increased dose in days Date taken away
Medication prescribed in trial period
Date prescribed Prescribed by Drug name Total amount of doses prescribed Generic name Drug typetablets oral mixture injection liquid etc Administration route Amount per dose Measured as ml mg etc Times a day in good periods Times a day in bad periods or prodromal stages Max Duration of increased dose in days Date taken away ATTACHMENT 8 Skin prick tests The skin prick tests are performed with a lancet with a one mm tip ALK All the tests will be performed in duplicate according to the EAACI Position paper ie the tests will be placed in a mirror fashion on the volar aspect of the forearm The reactions will be read after 15 minutes The weals are to be circumscribed by a fine filter pen or ballpoint pen on the red skin around the weal near the weal edge A transparent tape strip is to be pressed over the circumscription and transferred over to the registration sheet The weal size is to be recorded by assessment of the average weal diameter Weals with an average diameter 3 mm will be considered positive
Skin prick test protocol - allergen extract solutions and reference solutions Skin prick tests shall be performed at the inclusion of the patients at visit 1 SepOct-05 Soluprick extract solutions from ALK will be applied
Specifications
1 Birch Soluprick SQ ALK Abello 108 Silver birch 10 HEP
2 Timothy Soluprick SQ ALK Abello 225 Timothy grass 10 HEP
3 Mugwort Soluprick SQ ALK Abello 312 Mugwort 10 HEP
4 House dust mite Soluprick SQ ALK Abello 504 D Farinae 10 HEP
5 House dust mite Soluprick SQ ALK Abello 503 D Pteronyssin 10 HEP
6 Mould Soluprick SQ ALK Abello 417 Cladosporium herbarum 120 wv
7 Mould Soluprick SQ ALK Abello 402 Alternaria alternata 120 wv
8 Dog Soluprick SQ ALK Abello 553 Dog hair 10 HEP
9 Cat Soluprick SQ ALK Abello 555 Cat hair 10 HEP
10 Horse Soluprick SQ ALK Abello 552 Horse hair 10 HEP Soluprick ALK Abello Negative Control will be used as negative control and Soluprick ALK Abello Positive Control histamine dihydrochloride 10 mgml ALK as positive control
ATTACHMENT 9 - SPECIFIC IGE A blood sample is to be taken at visit 1 in SepOct-05 for specific IgE for the same allergens as the skin prick tests except for Dpteronyssinus Reagents from Pharmacia Diagnostics will be applied and their procedures for blood sampling and analyses will be applied EMLA Astra-Zeneca cream can be used if wanted as a topic anaesthetic agent before blood sampling
ATTACHMENT 10 - serum ECP At both visits blood samples will be taken for serum ECP Reagents from Pharmacia Diagnostics will be used and their manuals for blood sampling and analyses applied
AIM
To examine if powerful air cleaners with HEPA-filters and a pre-set speed function making it possible to run the air cleaners at a high but noisy speed at acceptable times and if wanted at a lower but less noisy speed at other times Icleen IQAir have a favourable effect on asthma in children and adolescents aged 8-17 years who are allergic to dogs but not to house dust mite To look at this study separately but also look upon the total results of this study and a previous study performed by the project leader
BACKGROUND
The first study is not yet published We found signs of clinically significant effects of active air cleaners by the parameters ECP in serum and bronchial hyperreactivity by a cold air hyperventilation test but the results gave p-values at the border of statistical significance p0104 for FEV1 reduction and significant results p0018 for differences in the change of ECP The number of patients included in the study was 49 a lower number than wanted in the first place We did not find significant effects on Liz Junipers Life Quality Scale scores Yet there are reasons to believe that the results of the first study may have clinical significance A cold air hyperventilation test reflects a real life situation in interior parts of Norway resembling outdoor winter conditions strongly In the first study Allergy Control encasing over pillows eiderdowns and mattresses were applied compared to placebo but no signs of effects were found on these children aged 7 to 17 with allergy to dog or cat but not to house dust mites The reason to exclude house dust mite allergic patients in the first trial was to examine if encasings could have any effect on patients without house dust mite allergy and the fact that house dust mite allergy is less common in Northern interior areas where the trial took place Other studies indicate however that air cleaners can reduce allergens from dogs and cats but not most other indoor allergens 3 We want to perform a new trial and publish the results from each trial in one publication but also look upon the results of a meta-analysis of both studies Our hope is that the two trials can give more reliable information about the effects of the air cleaners This time no dust analyses will be taken because dust analyses from the first trial sent to dr Susanne Lau at the Charité-Virchow Clinic in Berlin showed that the air cleaners removed considerable amounts of dust personal message from dr Lau The results have been summarised in an article by Groth C et al in Allergy in 2002 and a manuscript for an article is now sent to Allergy for publication The efficiency of IQAir air cleaners has also been documented by Stiftung Warentest in Germany Due to limited resources and the signs of low sensitivity in such a trial Liz Junipers Life Quality Scale will not be applied this time For economic reasons hair samples for nicotine analysis will not be taken this time
Since the first trial was completed an important improvement of the air cleaners has arisen A new panel makes it possible to pre-set the air cleaners at different speeds or on and off at different times of the day at different days of the week Once a day the speed can be changed to another speed or turned off and once a day it can be turned back to the original speed in advance In addition the pre-set function can be overridden manually at any time In the first trial the timer on and off function could turn the air cleaners off once a day and on once a day with no active cleaning during the timer off intervals and no weekday differentiation of the timer This improvement increases the likelihood that the air cleaners will be used at higher and more noisy speeds at times when nobody is at home resulting in lower levels of flying allergen dust levels even at times when people are at home
In the first trial we did not find significantly stronger effects in homes with animals than in homes without animals Only a fourth of the homes had animals through the whole trial period For this reason we will only include homes without pets this time in order to get a more homogenous population In the first trial we had a lower age limit of 7 This time the lower age limit is 8 to make it easier for patients to co-operate avoiding frustration for seven-year-olds who may be excluded due to co-operation difficulties The reason that we require dog allergy this time not dog or cat allergy as in the first trial is that one trial indicates that air cleaners only reduce the amount of airborne cat allergens marginally if no cat is in the room This trial was performed in homes with cats 5 On the other hand a trial of effects of air cleaners in homes with dogs showed a significant reduction of dog allergens even in rooms where dogs were not present 1 The studies are difficult to compare however because different dust sampling methods were applied
MATERIAL
30 patients from Hedmark county in south-eastern Norway will be examined for the study at the start The patients will be selected from journals of patients having visited the hospital for asthma during the previous three years having had verified allergy against dog but not house dust mite
TRIAL DESIGN
1 Active group IQAir air cleaners one in the patients bedroom and one in the room mostly used by the patient outside the bedroom with real pre- and main filters
2 Placebo group As above but the main filter substituted by a placebo filter If the parents of the child do not live together and the child visits the other parent at least every second weekend both parents will be supplied with air cleaners of the same type with equivalent placing of the cleaners
The air cleaners are labelled either A or B indicating if they are real or fake Until closing of the trial only the manufacturer will know the code The patients will be randomised either to A or B with no stratification The air cleaners are sealed Hence it is not possible to open them to see what kind of filters they have without breaking the seal Even the placebo filters will seem real for people not accustomed to looking inside air cleaners
Protocol attachments
Skin prick tests and specific IgE will only be performed at visit 1 Other examinations and questions applied at both visits
ATTACHMENT 1 Clinical examination
Height weight inspection of thorax any stridor must be recorded respiration frequency lung auscultation The signs recorded after the Kjell Aas scale from P0 to P6
P0 Normal P1 No discomfort Slightly weakened auscultatory ventilation sound P2 No discomfort A few sibili fine wheezing sounds or rhonchi at auscultation Prolonged audible expirium No retractions
P3 No discomfort at rest Abundant obstructive sounds Slight jugular retraction some use of auxiliary ventilation muscles Possibly elevated shoulders
P4 Some discomfort at rest Abundant obstructive sounds Fine wheezing heard without stethoscope Jugularintercostal retractions Use of auxiliary ventilation muscles Worse P5 after cough
P5 Considerable discomfort at rest Abundant obstructive sounds Wheezing expiration Wheezing without stethoscope Energetic use of auxiliary ventilation muscles Possibly slight cyanosis
P6 Alarming obstruction Often even inspiratory obstruction NB Weak respiratory sounds but retractions and use of auxiliary muscles and tachypnoea are especially alarming Possible cyanosis
ATTACHMENT 2 Cold air provocation test - method Material
1 Rhes-pro cold air unit delivering cold air with a 52 CO2 content to avoid hypocapnia at hyperventilation The apparatus must be calibrated to give a standardised temperature -15C of the inhaled air at lip level and 52 CO2
2 Flow volume spirometer with computer
3 Before the test one must make sure that there is enough air and CO2 for the unit
Medication
Drugs that can affect the results must be avoided at a certain interval In our study the following drugs are withheld at the indicated intervals before the test
Short acting beta-2-agonist 12 hours
Long acting beta-2-agonist 24 hours
Beta-2-agonist slow release oral drugs Generally not used in our clinic If yet taken 3 days
Theophylline slow release oral drugs Generally not used in our clinic If yet taken 3 days
Antihistamines 7 days
Leukotriene antagonists 48 hours
Atropine derivatives ipratropium bromide 8 hours After the test the patient can be given the rest of his ordinary morning drugs
Time of the day
1 The test should be performed at the same time every time preferably in the morning
2 The patient should rest for 15 minutes before the test to avoid influence by physical exercise bicycling running up stairs etc
Test method
1 Tests performed on Mondays must be avoided to prevent influence by casual contacts and activities in the course of the weekend before the test
2 Travels including staying overnight away from the home for more than a week should be registered and the test should be performed more than one week after arriving home from holiday
3 The patient must have normal clinical signs P0 before the cold air provocation or the test must be postponed
4 Take flow volume test best FEV1 out of 3 attempts A printout of the best spirometry attempt must be stored in the research archive The flow volume tests shall be performed in a sitting position The patient must use a nose clip during spirometry and cold air provocation
5 Provided FEV1 is 70 of predicted the test is started If 70 it is postponed
6 The air mixture flow is calculated by the pre-provocation best FEV1 value by multiplying FEV1 by 20 for children less than 13 years of age at the first visit and by 26 for the adolescents more than 13 years of age at the first visit The patient remains sitting during the cold air provocation
7 The patient is instructed to breathe rapidly and deeply through the mouthpiece during the provocation which lasts for 4 minutes In practice the test is performed by letting the child breathe sufficiently to keep a connected balloon or ventilation bag halfway filled
8 Spirometry with FEV1 must be performed straight before and 2 minutes after provocation
9 MEF50 FEF50 at each spirometry being recorded as the spirometry giving the best FEV1 will be registered
10 Auscultation signs immediately before each series of three spirometry attempts and possible cough will be registered
11 After the post-provocation spirometry two minutes after the provocation salbutamol Ventolin 01mg meter dose inhaler by Volumatic will be given for reversibility test 2 puffs for patients weighing less than 45 kg and 4 puffs for patients weighing 45 kg and more one puff at a time 5 inhalations per puff New spirometry will be performed 5 minutes after giving Ventolin and FEV1 is registered again in absolute value and percentage of the first value before cold air provocation
12 Even if the risk for acute severe asthmatic symptoms is low a nebuliser for giving salbutamol and adrenaline for subcutaneous injection and equipment for intravenous administration of antiasthmatic drugs will be easily availableThe treatment scheme from the Norwegian Paediatric Associations acute therapy book will be applied Evaluation of the test results Percentage fall in FEV1 and FEF50 will be applied as a parameter of bronchial reactivity More than 10 fall in FEV1 after cold air or more than 10 rise in FEV1 after inhalation of Ventolin is considered significant
Printouts of the spirometry results will be saved Patient registration sheet cold air hyperventilation test Printouts from spirometry to be attached
The following data will be noted
Time of day hours minute Height cm Weight kg Assisted by nurse Assisted by doctor
Questions to be asked
Staying away from home for more than 2 weeks last month or during trial Staying overnight away from home last week Staying overnight for more than a week less than one week ago Inhaled drugs - Ventolin Serevent Flutide doses numbers of hours ago Other drugs route Dose x times a day Last dose number of hours ago
To be recorded from spirometry
Best FEV1 pre-test litres per minute Temperature at mouthpiece will be held at -15 C Air flow in cold unit litres per minute CO2 flow in cold unit litres per minute Number of minutes of provocation Number of pauses Patients performance will be recorded as good acceptable or unacceptable
The following values and signs noted before provocation 2 minutes after provocation and 5 minutes after Ventolin given in a spacer Volumatic
FEV1 FEV1 increase or decrease - of pre-test MEF50 MEF50 of first Aas score P0-P6 Cough Other signs or symptoms If other rescue medication is given than Ventolin in Volumatic it must be noted
ATTACHMENT 3 Inquiry about animal contact
1 Are there pets in the home
2 Did you react by nose symptoms sneezing cough or breathing difficulties the last time you were close to a dog without having taken drugs against asthma or allergy
3 What kind of pet do you have in the home
If animal removed the last half year how many months ago Animal now Number of animals Specify if you have cat dog rabbit hamster other furred pets budgerigar other birds fish other animals
4 Are you patient in contact with animals outside the home How often what kind of animal ATTACHMENT 4 Inquiry about smoking The staff fill in questions to patient if the patient or anybody else in the home smokes and if smoking in the home totals less than 10 10-20 or more than 20 cigarettes a day
ATTACHMENT 5 Questions about fitted carpets humidity vacuum cleaners mechanical ventilation systems
The following questions are asked by staff to parent or accompanying person what person will be recordedFilled in together with
1 Do you have fitted carpets
2 Do you have fitted carpets in the childs bedroom
3 Do you have fitted carpets in the living room
4 Do you have fitted carpets in other rooms
5 Do you think that you have more than 5 cm of dew or frost on the inside of the window of the childs bedroom
6 Is there any smell of mould in your house
7 Where in the house is there a smell of mould
8 Can you see mould or rotten patches in any room
9 If yes where can you see it
10 What kind of vacuum cleaner do you have
11 Is there except for ventilation over the kitchen stove any kind of mechanical ventilation or air filtration in the home ATTACHMENT 6 Symptom score The patients are asked to draw a circle around one of the numbers from 1 through 5 indicating the degree of symptoms 1 meaning no or never 5 meaning many times each night severe always cannot breathe through my nose or cannot breathe through my nose while sitting still respectively For patients taking antihistamines the nose symptoms are valid for the last 5 days Otherwise the questions are applicable to the last month
Questions to patients at Visit 1 SepOct-05
1 Do you wake up at night due to asthma
2 How is your asthma during daytime
3 Do you feel your asthma when you run
4 Is your nose stuffy at night To patients who have taken antihistaminic agents regularly for the last month this question will be asked instead Has your nose been stuffy in daytime for the last 5 days
5 Is your nose stuffy during daytime To patients who have taken antihistaminic agents regularly for the last month this question will be asked instead Has your nose been stuffy in daytime for the last 5 days Finally a question is asked about strong asthma attacks last 3 months Options for answers ar no once or several times
ATTACHMENT 7 Medication Prophylactic medication will be kept constant during the trial Doubling doses of inhaled steroids for maximum two weeks during exacerbations or airway infections or in patients not taking inhaled steroids daily taking inhaled steroids for maximum two weeks during exacerbations or airway infections will be accepted Systemic corticosteroids in the trial period will lead to exclusion
Ongoing medication See section about cold air challenge attachment 2
Pre-trial medication
Date prescribed or 1-3 between 1 and 3 months ago or 3 more than 3 months ago Drug name Total amount of doses prescribed Generic name Drug type tablets oral mixture injection liquid etc Administration route Amount per dose Measured as ml mg etc Times a day in good periods Times a day in bad periods or prodromal stages Max duration of increased dose in days Date taken away
Medication prescribed in trial period
Date prescribed Prescribed by Drug name Total amount of doses prescribed Generic name Drug typetablets oral mixture injection liquid etc Administration route Amount per dose Measured as ml mg etc Times a day in good periods Times a day in bad periods or prodromal stages Max Duration of increased dose in days Date taken away ATTACHMENT 8 Skin prick tests The skin prick tests are performed with a lancet with a one mm tip ALK All the tests will be performed in duplicate according to the EAACI Position paper ie the tests will be placed in a mirror fashion on the volar aspect of the forearm The reactions will be read after 15 minutes The weals are to be circumscribed by a fine filter pen or ballpoint pen on the red skin around the weal near the weal edge A transparent tape strip is to be pressed over the circumscription and transferred over to the registration sheet The weal size is to be recorded by assessment of the average weal diameter Weals with an average diameter 3 mm will be considered positive
Skin prick test protocol - allergen extract solutions and reference solutions Skin prick tests shall be performed at the inclusion of the patients at visit 1 SepOct-05 Soluprick extract solutions from ALK will be applied
Specifications
1 Birch Soluprick SQ ALK Abello 108 Silver birch 10 HEP
2 Timothy Soluprick SQ ALK Abello 225 Timothy grass 10 HEP
3 Mugwort Soluprick SQ ALK Abello 312 Mugwort 10 HEP
4 House dust mite Soluprick SQ ALK Abello 504 D Farinae 10 HEP
5 House dust mite Soluprick SQ ALK Abello 503 D Pteronyssin 10 HEP
6 Mould Soluprick SQ ALK Abello 417 Cladosporium herbarum 120 wv
7 Mould Soluprick SQ ALK Abello 402 Alternaria alternata 120 wv
8 Dog Soluprick SQ ALK Abello 553 Dog hair 10 HEP
9 Cat Soluprick SQ ALK Abello 555 Cat hair 10 HEP
10 Horse Soluprick SQ ALK Abello 552 Horse hair 10 HEP Soluprick ALK Abello Negative Control will be used as negative control and Soluprick ALK Abello Positive Control histamine dihydrochloride 10 mgml ALK as positive control
ATTACHMENT 9 - SPECIFIC IGE A blood sample is to be taken at visit 1 in SepOct-05 for specific IgE for the same allergens as the skin prick tests except for Dpteronyssinus Reagents from Pharmacia Diagnostics will be applied and their procedures for blood sampling and analyses will be applied EMLA Astra-Zeneca cream can be used if wanted as a topic anaesthetic agent before blood sampling
ATTACHMENT 10 - serum ECP At both visits blood samples will be taken for serum ECP Reagents from Pharmacia Diagnostics will be used and their manuals for blood sampling and analyses applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PARTIAL SPONSOR INCEN AG | None | None | None |