Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765722
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-15
First Post:
2021-02-05
Brief Title:
Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
MUCOSA
Brief Summary:
Cough is the most common presenting symptom to family physician Chronic Cough affects approximately 10-12 of the general population and is one of the commonest reasons for referral to secondary care Unfortunately there are no licensed treatments for this debilitating condition which is associated with a poor quality of life affecting the social physical and psychological well-being of patients
The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough Secondary outcomes including the effects on quality of life the intensity of irritant sensations airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated
The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis thereby causing a reduction in objective cough frequency
The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough Secondary outcomes including the effects on quality of life the intensity of irritant sensations airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated
The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis thereby causing a reduction in objective cough frequency
Detailed Description:
This is a 9-visit randomized double-blind placebo-controlled parallel-group Phase IV study The purpose of this study is to evaluate the effectiveness of mepolizumab for the treatment of refractory chronic cough in patients with eosinophilic airway disease Patients will be recruited from secondary care clinics Patient eligibility will be assessed against the study inclusionexclusion criteria and patients will undergo informed consent in the research centre Subjects who provide informed consent and are enrolled in the study will undergo screening procedures
The study will consist of a Mepolizumab treatment arm and placebo arm normal saline Fifteen subjects will be randomly assigned to the treatment arm and fifteen subjects will be randomly assigned to the placebo arm in a 11 ratio Following screening and randomization subjects will under an 12-week treatment period during which they will receive 4 doses of the study drug at days 0 28 56 and 84 The primary study outcomes will be measured at week 14 week 2 weeks following the treatment period
At Visit 1 screening subjects will undergo screening procedures complete medical history physical examination methacholine challenge spirometry sputum induction and blood sampling Subjects will complete the Leicester Cough Questionnaire and modified Borg Scale
At Visit 2 subjects will be fitted with a 24-hour cough monitor
At Visit 3 24-hour cough monitors will be removed and subjects will undergo spirometry blood sampling and sputum induction Subjects will complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The first dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 4 subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The second dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 5 the third dose of the study drug will be administered in the clinical research facility by a study physician Subjects will be fitted with a 24-hour cough monitor
At Visit 6 24-hour cough monitors will be removed and subjects will undergo spirometry sputum induction and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale
At Visit 7 subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The fourth dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 8 subjects will be fitted with a 24-hour cough monitor
At Visit 9 the 24-hour cough monitors will be removed and subjects will undergo spirometry methacholine challenge sputum induction and blood sampling Subjects will complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale
All study procedures will be performed according to local standard operating procedures and be conducted by trained and experienced staff with supervision by medical doctors Study physicians will administer all study drug injections Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events
The study will consist of a Mepolizumab treatment arm and placebo arm normal saline Fifteen subjects will be randomly assigned to the treatment arm and fifteen subjects will be randomly assigned to the placebo arm in a 11 ratio Following screening and randomization subjects will under an 12-week treatment period during which they will receive 4 doses of the study drug at days 0 28 56 and 84 The primary study outcomes will be measured at week 14 week 2 weeks following the treatment period
At Visit 1 screening subjects will undergo screening procedures complete medical history physical examination methacholine challenge spirometry sputum induction and blood sampling Subjects will complete the Leicester Cough Questionnaire and modified Borg Scale
At Visit 2 subjects will be fitted with a 24-hour cough monitor
At Visit 3 24-hour cough monitors will be removed and subjects will undergo spirometry blood sampling and sputum induction Subjects will complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The first dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 4 subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The second dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 5 the third dose of the study drug will be administered in the clinical research facility by a study physician Subjects will be fitted with a 24-hour cough monitor
At Visit 6 24-hour cough monitors will be removed and subjects will undergo spirometry sputum induction and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale
At Visit 7 subjects will undergo spirometry and blood sampling and complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale The fourth dose of the study drug will be administered in the clinical research facility by a study physician
At Visit 8 subjects will be fitted with a 24-hour cough monitor
At Visit 9 the 24-hour cough monitors will be removed and subjects will undergo spirometry methacholine challenge sputum induction and blood sampling Subjects will complete the Leicester Cough Questionnaire modified Borg Scale and Cough Severity Visual Analogue Scale
All study procedures will be performed according to local standard operating procedures and be conducted by trained and experienced staff with supervision by medical doctors Study physicians will administer all study drug injections Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None