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Prospective Study on the Evaluation, Patient Reported Outcomes and Effectiveness of Treatment for Chronic Cough

Chronic Cough

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 75

Participation Criteria

Inclusion Criteria:

1. Aged ≥18-75
2. Patients referred to a specialist primarily with a history of chronic cough (cough lasting \>8 weeks)
3. Normal Chest X-ray
4. No Evidence of Airflow Obstruction

Exclusion Criteria:

1. Subjects who are currently established on treatment and their chronic cough is well controlled.
2. Unable to perform acceptable and reproducible spirometry.
3. Current smoker or ex-smoker with ≥20 pack-year smoking history and abstinence of ≤6 months
4. Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
5. Lower respiratory tract infection or pneumonia in the last 1 month
6. Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid or oral corticosteroid
7. Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
8. 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.
9. History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
10. Positive Covid-19 test within 2 weeks of screening visit.

Study Location

Imran Satia
Imran Satia
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Imran Satia, MD PhD

[email protected]
Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT04758351