Status:
COMPLETED
Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Merck Canada Inc.
University of Manchester
Conditions:
Chronic Cough
Eligibility:
All Genders
18-75 years
Brief Summary
Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. The aim of this study is to evaluate the effectiveness of ...
Detailed Description
This is a prospective observational single-center study of patients referred to secondary care for investigation and management of explained chronic cough, refractory chronic cough, and unexplained ch...
Eligibility Criteria
Inclusion
- Aged ≥18-75
- Patients referred to a specialist primarily with a history of chronic cough (cough lasting \>8 weeks)
- Normal Chest X-ray
- No Evidence of Airflow Obstruction
Exclusion
- Subjects who are currently established on treatment and their chronic cough is well controlled.
- Unable to perform acceptable and reproducible spirometry.
- Current smoker or ex-smoker with ≥20 pack-year smoking history and abstinence of ≤6 months
- Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
- Lower respiratory tract infection or pneumonia in the last 1 month
- Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid or oral corticosteroid
- Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
- Any centrally acting medication within the last 2 weeks which in the view of the investigator could influence the coughing. Any participant who is taking amitriptyline, dextromethorphan, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication before the start of visit 1. The reason for this is that centrally-acting medications may influence coughing rates at baseline.
- History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
- Positive Covid-19 test within 2 weeks of screening visit.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04758351
Start Date
December 14 2021
End Date
April 30 2025
Last Update
May 6 2025
Active Locations (1)
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1
Imran Satia
Hamilton, Ontario, Canada, L8S 4L8