Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04758351
Study type Observational
Source McMaster University
Contact Imran Satia, MD, PhD
Phone 905-521-2100
Email satiai@mcmaster.ca
Status Recruiting
Phase
Start date December 14, 2021
Completion date April 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT01432730 - A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006) Phase 2
Not yet recruiting NCT01413698 - Cough Count Validation N/A
Completed NCT03639727 - Cough in Eastern and Central Finland N/A
Completed NCT03696108 - A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038) Phase 3
Recruiting NCT03638063 - ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis
Recruiting NCT06376448 - An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
Completed NCT03172130 - Sham CPAP vs. Straight CPAP for Chronic Cough N/A
Recruiting NCT06286163 - Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients
Completed NCT03622216 - A Dose Escalation Study of Bradanicline in Refractory Chronic Cough Phase 2
Recruiting NCT05522699 - Cough Suppressive Therapy in Patients With Chronic Cough N/A
Completed NCT01297790 - Cough Responses to Tussive Agents in Health and Disease N/A
Completed NCT04193202 - Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043) Phase 3
Completed NCT01865422 - French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL) N/A
Completed NCT04525885 - A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension Phase 3
Completed NCT04193176 - Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042) Phase 3
Recruiting NCT05362097 - Analysis of the Reliability and Validity of the Chinese Version of CC-QoL
Recruiting NCT03787511 - Chronic Cough and Small Fiber Neuropathy N/A
Terminated NCT03864328 - A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF Phase 2
Completed NCT05274516 - A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration Phase 1
Not yet recruiting NCT01807832 - The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough. N/A