Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00633919
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-03-04
Brief Title:
Efficacy of SLITone in House Dust Mite Allergic Patients
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma based on asthma medication use during a period of 2 months with a high environmental exposure to mites autumn 2008
Detailed Description:
This trial was conducted as a multi-centre randomised double-blind parallel-group placebo-controlled phase III trial assessing the efficacy of SLITone Dermatophagoides mix in adults 18-65 years 5 centres in Spain participated
Subjects with house dust mite allergic asthma were randomised to receive either SLITone Dermatophagoides mix active or placebo treatment 11 for approximately 1 year The trial duration was extended to 2 years Administration was done sublingually under the tongue once daily preferably in the morning A monodose container comprised the daily dose of 200 STU
Subjects were kept in asthma control during the entire trial 2 years Except for during 2 evaluation periods of 2 months in autumn 2007 and autumn 2008 subjects used the medications prescribed by their physician During the 2 evaluation periods of 2 months in autumn 2007 and autumn 2008 subjects used provided and standardised rhinoconjunctivitis and asthma medications The asthma medication use was to reflect the subjects asthma status This was done by treatment with a low maintenance dose of control medication supplemented with rescue medication as needed
Rhinoconjunctivitis medication during the 2 evaluation periods in autumn 2007 and autumn 2008 to standardise the medication used to relieve rhinoconjunctivitis symptoms subjects were provided with the following free medications as needed
Desloratadine tablet 5 mg per tablet anti-histamine Aerus
Budesonide nasal spray 64 µg per puff inhaled corticosteroid
Prednisone tablet 5 mg per tablet oral corticosteroid
Subjects were instructed to use this medication instead of their usual medication during the 2 evaluation periods in autumn 2007 and autumn 2008 and to record the used medication and symptoms in the daily diary
Asthma medication during the evaluation period in autumn 2007 prior to the 2 months evaluation period in autumn 2007 the asthma control medication use was interrupted to obtain a medication-free period Subjects were provided with the following free medications to standardise the treatment used to relieve asthma symptoms
Salbutamol inhaler 200 µg per puff a short acting β2-agonist Ventilastin
Budesonideformoterol inhaler 8045 µg per inhalation a combination of inhaled corticosteroids and long acting β2-agonist Symbicort
Prednisone tablet 5 mg per tablet oral corticosteroid
Subjects were instructed to use this medication instead of their usual medication during the evaluation period in autumn 2007 as follows
They were to use salbutamol inhaler as asthma rescue medication until they either
needed more than 4 inhalations of salbutamol per day for 2 consecutive days
suffered from nocturnal asthma forcing them to wake up
suffered from exercise-induced dyspnoea doing ordinary tasks In these cases subjects were to contact the investigator to determine the amount of budesonideformoterol to use as daily asthma control medication The budesonideformoterol inhaler was thereafter to be used as rescue medication as needed instead of salbutamol Prednisone could be used as a last option
Asthma medication during the evaluation period in autumn 2008 At the 2 months evaluation period in autumn 2008 subjects were maintained at a low dose of budesonideformoterol daily asthma control medication and they used the budesonideformoterol inhaler as rescue medication as needed Prednisone could be used as a last option
Asthma medication used during the evaluation periods in autumn 2007 and autumn 2008 were recorded in a daily diary
One primary efficacy endpoint and 16 secondary efficacy endpoints were assessed the result of the primary efficacy endpoint 3 secondary endpoints and adverse event reportings are posted here None of the other secondary endpoints demonstrated a difference between treatment groups
Subjects with house dust mite allergic asthma were randomised to receive either SLITone Dermatophagoides mix active or placebo treatment 11 for approximately 1 year The trial duration was extended to 2 years Administration was done sublingually under the tongue once daily preferably in the morning A monodose container comprised the daily dose of 200 STU
Subjects were kept in asthma control during the entire trial 2 years Except for during 2 evaluation periods of 2 months in autumn 2007 and autumn 2008 subjects used the medications prescribed by their physician During the 2 evaluation periods of 2 months in autumn 2007 and autumn 2008 subjects used provided and standardised rhinoconjunctivitis and asthma medications The asthma medication use was to reflect the subjects asthma status This was done by treatment with a low maintenance dose of control medication supplemented with rescue medication as needed
Rhinoconjunctivitis medication during the 2 evaluation periods in autumn 2007 and autumn 2008 to standardise the medication used to relieve rhinoconjunctivitis symptoms subjects were provided with the following free medications as needed
Desloratadine tablet 5 mg per tablet anti-histamine Aerus
Budesonide nasal spray 64 µg per puff inhaled corticosteroid
Prednisone tablet 5 mg per tablet oral corticosteroid
Subjects were instructed to use this medication instead of their usual medication during the 2 evaluation periods in autumn 2007 and autumn 2008 and to record the used medication and symptoms in the daily diary
Asthma medication during the evaluation period in autumn 2007 prior to the 2 months evaluation period in autumn 2007 the asthma control medication use was interrupted to obtain a medication-free period Subjects were provided with the following free medications to standardise the treatment used to relieve asthma symptoms
Salbutamol inhaler 200 µg per puff a short acting β2-agonist Ventilastin
Budesonideformoterol inhaler 8045 µg per inhalation a combination of inhaled corticosteroids and long acting β2-agonist Symbicort
Prednisone tablet 5 mg per tablet oral corticosteroid
Subjects were instructed to use this medication instead of their usual medication during the evaluation period in autumn 2007 as follows
They were to use salbutamol inhaler as asthma rescue medication until they either
needed more than 4 inhalations of salbutamol per day for 2 consecutive days
suffered from nocturnal asthma forcing them to wake up
suffered from exercise-induced dyspnoea doing ordinary tasks In these cases subjects were to contact the investigator to determine the amount of budesonideformoterol to use as daily asthma control medication The budesonideformoterol inhaler was thereafter to be used as rescue medication as needed instead of salbutamol Prednisone could be used as a last option
Asthma medication during the evaluation period in autumn 2008 At the 2 months evaluation period in autumn 2008 subjects were maintained at a low dose of budesonideformoterol daily asthma control medication and they used the budesonideformoterol inhaler as rescue medication as needed Prednisone could be used as a last option
Asthma medication used during the evaluation periods in autumn 2007 and autumn 2008 were recorded in a daily diary
One primary efficacy endpoint and 16 secondary efficacy endpoints were assessed the result of the primary efficacy endpoint 3 secondary endpoints and adverse event reportings are posted here None of the other secondary endpoints demonstrated a difference between treatment groups
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 |
|---|---|---|---|
| EudraCT - 2005-004731-21 | None | None | None |