Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of the Inhaled Triple Therapies Over the Small Airway in Patients With Chronic Obstructive Pulmonary Disease or Chronic Bronchitis Without Obstruction Secondary to Biomass Exposure Randomized Controlled Clinical Trial Phase IV
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IV randomized controlled clinical trial intend to compare the effect of three close standard inhaled triple therapies and one close standard inhaled double therapy on the small airway in patients with Chronic Obstructive Pulmonary Disease COPD-B and chronic bronchitis without obstruction BCNO exposed to wood smoke The treatment phase duration is of 3 months As primary outcome the resistance change in post-bronchodilatator impulse oscilometry will me measure at 30 minutes 2 hours 4 hours and 24 hours post first dose of the asigned medication and then at 1 and 3 months of treatment As secondary outcomes change in respiratory symptoms and health related quality of life will be assess after 1 and 3 months of treatment
Detailed Description:
Selection visit day -21 to -1 The diagnosis of COPD-B or BCNO will be verified The inclusion criteria will be checked and it will be verified if there are any exclusion criteria clinical record will be reviewed if necessary The patient is invited to the study will be given detailed information about it and a copy of the informed consent for evaluation If they agree to participate in the study they will be asked to sign the consent in the indicated space as well as two witnesses If the patient does not have post-bronchodilator forced spirometry and a six-minute walk in the last 3 weeks these tests will be performed in the COPD lung function laboratory A symptom diary will be dispensed and training will be given on how to fill it out The patient will be instructed to begin the washout time which will be one week for long-acting bronchodilators LAMA or LABA or LAMALABA combination and 3 weeks for inhaled steroids or ICSLABA ICSLAMALABA During this period patients will be able to use their rescue bronchodilator SAMA SABA or combination by schedule They will be instructed in the identification of exacerbations and alarm symptoms and if necessary communicate with the principal investigator
Randomization visit and initiation of treatment Visit 0 day 0 A complete patient history will be taken with main emphasis on the recording of comorbidities and concomitant medication Inclusion and exclusion criteria will be checked The washout time of each bronchodilator will be confirmed and once confirmed baseline questionnaires will be performed Measurement of dyspnea mMRC scale and health realated quality of life questionnaires CAT and SGRQ The history of exacerbations in the last 4 weeks will be verified If the patient continue to meet the criteria they will be selected and baseline respiratory function tests will begin The tests will be performed between 700 to 800 AM in the following order Exhaled fraction of nitric oxide FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography The selection criteria will be confirmed and if they are a candidate randomization will be carried out through the Redcap program Patients will be assigned one of the four devices contemplated for the study The first group will be assigned the device containing VilanterolUmeclidinium 25625 mcg Anoro with a dose of one inhalation every 24 hours the second group will be assigned the device containing Fluticasone Vilanterol Umeclidinium 10025625 mcg Trelegy with a dose of one inhalation every 24 hours the third group will be assigned the device containing Beclomethasone Formoterol Glycopyrronium 1006125 mcg Trimbow with doses of two inhalations every 12 hours the forth group will be assigned the device containing BudesonideFormoterolGlycopyrronium 1604872 mcg with doses of two inhalations every 12 hours Each patient will be given a 100 μg salbutamol device as rescue medication
Once the study medication is assigned they will be instructed in technique and dosage and a corresponding dose will be applied A blood sample will be taken for a blood count and IgE test and Th2 and Th17 inflammatory profile cytokines After 30 minutes of application of the study medication impulse oscillometry slow spirometry and forced spirometry will be performed After 2 hours of application of study medication impulse oscillometry slow spirometry and forced spirometry will be performed After 4 hours of application of study medication impulse oscillometry slow spirometry and forced spirometry will be performed At the end of the respiratory function tests the patient will be referred to the imaging service for tomography evaluation if it is not available with volumetry in the last year Adverse events will be measured at baseline for the safety outcome The patient will be instructed in the use of the assigned medication technique frequency of use as well as information and training on possible side effects Visit 1 will be scheduled the next day without a window period
Follow-up visit 1 Visit 1 Day 1 Changes in respiratory symptoms presence of adverse events and use of concomitant medication will be questioned and documented Symptom diary will be reviewed It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC and quality of life questionnaire CAT will be completed Pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Standard doses of SABA 400 mcg of salbutamol will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry slow spirometry and forced spirometry will be performed The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied Study medication will be provided for one month of treatment A symptom diary will be provided and a follow-up visit 2 will be scheduled 30 days after the randomization visit
Follow-up visit 2 Visit 2 30 days -21 day Exacerbations during the period frequency of adverse events newly diagnosed comorbidities and use of concomitant medication will be questioned and documented Symptom diary will be reviewed Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment 80 It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC quality of life questionnaire Saint George and CAT and adherence to inhaled medication questionnaire TAI will be completed Baseline pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Short-acting bronchodilator SABA will be applied the patient will be left to rest for 20 minutes Post-bronchodilator tests will be initiated in the following order impulse oscillometry slow spirometry forced spirometry The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied Study medication will be provided for two months of treatment A symptom diary will be provided and a follow-up visit 3 will be scheduled 12 weeks after the randomization visit Instructions for said visit will be given
Follow-up visit 3 Visit 3 12 weeks -21 day Exacerbations during the period frequency of adverse events newly diagnosed comorbidities and use of concomitant medication will be questioned and documented Symptom diary will be reviewed Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment 80 It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC quality of life questionnaire Saint George and CAT and adherence to inhaled medication questionnaire TAI will be completed Baseline pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Standard doses of SABA 400 mcg of salbutamol will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry slow spirometry and forced spirometry will be performed Participation in the protocol will be terminated and monitoring by the NIRD Tobacco and COPD clinic will continue
Randomization visit and initiation of treatment Visit 0 day 0 A complete patient history will be taken with main emphasis on the recording of comorbidities and concomitant medication Inclusion and exclusion criteria will be checked The washout time of each bronchodilator will be confirmed and once confirmed baseline questionnaires will be performed Measurement of dyspnea mMRC scale and health realated quality of life questionnaires CAT and SGRQ The history of exacerbations in the last 4 weeks will be verified If the patient continue to meet the criteria they will be selected and baseline respiratory function tests will begin The tests will be performed between 700 to 800 AM in the following order Exhaled fraction of nitric oxide FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography The selection criteria will be confirmed and if they are a candidate randomization will be carried out through the Redcap program Patients will be assigned one of the four devices contemplated for the study The first group will be assigned the device containing VilanterolUmeclidinium 25625 mcg Anoro with a dose of one inhalation every 24 hours the second group will be assigned the device containing Fluticasone Vilanterol Umeclidinium 10025625 mcg Trelegy with a dose of one inhalation every 24 hours the third group will be assigned the device containing Beclomethasone Formoterol Glycopyrronium 1006125 mcg Trimbow with doses of two inhalations every 12 hours the forth group will be assigned the device containing BudesonideFormoterolGlycopyrronium 1604872 mcg with doses of two inhalations every 12 hours Each patient will be given a 100 μg salbutamol device as rescue medication
Once the study medication is assigned they will be instructed in technique and dosage and a corresponding dose will be applied A blood sample will be taken for a blood count and IgE test and Th2 and Th17 inflammatory profile cytokines After 30 minutes of application of the study medication impulse oscillometry slow spirometry and forced spirometry will be performed After 2 hours of application of study medication impulse oscillometry slow spirometry and forced spirometry will be performed After 4 hours of application of study medication impulse oscillometry slow spirometry and forced spirometry will be performed At the end of the respiratory function tests the patient will be referred to the imaging service for tomography evaluation if it is not available with volumetry in the last year Adverse events will be measured at baseline for the safety outcome The patient will be instructed in the use of the assigned medication technique frequency of use as well as information and training on possible side effects Visit 1 will be scheduled the next day without a window period
Follow-up visit 1 Visit 1 Day 1 Changes in respiratory symptoms presence of adverse events and use of concomitant medication will be questioned and documented Symptom diary will be reviewed It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC and quality of life questionnaire CAT will be completed Pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Standard doses of SABA 400 mcg of salbutamol will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry slow spirometry and forced spirometry will be performed The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied Study medication will be provided for one month of treatment A symptom diary will be provided and a follow-up visit 2 will be scheduled 30 days after the randomization visit
Follow-up visit 2 Visit 2 30 days -21 day Exacerbations during the period frequency of adverse events newly diagnosed comorbidities and use of concomitant medication will be questioned and documented Symptom diary will be reviewed Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment 80 It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC quality of life questionnaire Saint George and CAT and adherence to inhaled medication questionnaire TAI will be completed Baseline pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Short-acting bronchodilator SABA will be applied the patient will be left to rest for 20 minutes Post-bronchodilator tests will be initiated in the following order impulse oscillometry slow spirometry forced spirometry The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied Study medication will be provided for two months of treatment A symptom diary will be provided and a follow-up visit 3 will be scheduled 12 weeks after the randomization visit Instructions for said visit will be given
Follow-up visit 3 Visit 3 12 weeks -21 day Exacerbations during the period frequency of adverse events newly diagnosed comorbidities and use of concomitant medication will be questioned and documented Symptom diary will be reviewed Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment 80 It will be confirmed that the patient has not applied the morning dose of study medication Dyspnea questionnaire mMRC quality of life questionnaire Saint George and CAT and adherence to inhaled medication questionnaire TAI will be completed Baseline pulmonary function tests will be performed FeNO impulse oscillometry slow spirometry forced spirometry and simple plethysmography Standard doses of SABA 400 mcg of salbutamol will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry slow spirometry and forced spirometry will be performed Participation in the protocol will be terminated and monitoring by the NIRD Tobacco and COPD clinic will continue
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