Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04758351
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough in Secondary Care
Status:
COMPLETED
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:
PROCOUGH
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 treatment, patient-reported outcomes and burden of disease in patients with chronic cough referred to a specialist clinic. The proposed study will use pre-defined diagnostic criteria, investigations and treatment algorithms such that all recruited patients will undergo the same investigations and follow a set management algorithm. This study will objectively and subjectively assess coughing at baseline and after treatment in a real-world clinical setting. This will allow us to understand the relationship between any objective reduction in cough after treatment, and whether this translates to any significant improvement in subjective questionnaire scores. We will assess the impact of health conditions on lost productivity in monetary units and assess the amount of absenteeism, presenteeism and daily activity impairment attributable to unexplained chronic cough/refractory chronic cough. Finally, a patient survey at the end of the study will evaluate the patients' satisfaction and experience of investigation, management trials and use of questionnaires.
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 chronic cough. The study will have 4 research visits integrated between standard clinical visits. Patients will be recruited from secondary care clinics. Patient eligibility will be assessed against the study inclusion/exclusion 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.
At Visit 1 (screening) data on demographics and medical history will be collected and a complete physical examination will be conducted. Subjects will undergo skin prick testing and spirometry and complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Healthcare Resource Utilization, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale). Subjects will be fitted with a 24-hour cough monitor.
At Visit 2, the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, methacholine challenge, sputum induction, and provide a urine sample.
Between Visits 2 and 3, physicians will provide a single clinical treatment pathway to address the most likely cause of chronic cough. Treatment for chronic cough will be in line with current clinical practice guidelines published by the European Respiratory Society Taskforce on Chronic Cough. Treatment plans will range from 2 weeks to 3 months.
Visit 3 will occur 2 weeks to 3 months following subjects' second clinical visit. Subjects will complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale) and be fitted with a 24-hour cough monitor.
At Visit 4 the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, sputum induction, and provide a urine sample. Subjects will complete a patient satisfaction survey.
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. Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events.
At Visit 1 (screening) data on demographics and medical history will be collected and a complete physical examination will be conducted. Subjects will undergo skin prick testing and spirometry and complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Healthcare Resource Utilization, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale). Subjects will be fitted with a 24-hour cough monitor.
At Visit 2, the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, methacholine challenge, sputum induction, and provide a urine sample.
Between Visits 2 and 3, physicians will provide a single clinical treatment pathway to address the most likely cause of chronic cough. Treatment for chronic cough will be in line with current clinical practice guidelines published by the European Respiratory Society Taskforce on Chronic Cough. Treatment plans will range from 2 weeks to 3 months.
Visit 3 will occur 2 weeks to 3 months following subjects' second clinical visit. Subjects will complete self-reported questionnaires (Leicester Cough Questionnaire, Valuation of Lost Productivity, Work Productivity, Activity, and Impairment, Reflux Disease Questionnaire, Sino-Nasal Outcome Test, and Global Rating of Change Scale) and be fitted with a 24-hour cough monitor.
At Visit 4 the 24-hour cough monitor will be removed. Subjects will undergo blood sampling, sputum induction, and provide a urine sample. Subjects will complete a patient satisfaction survey.
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. Safety will be assessed throughout the study by monitoring for adverse events and serious adverse events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: