Chronic cough treatment: the McGill experience

Not Applicable

Terminated

• Conditions: Chronic cough secondary to irritable larynx and post-viral neuropathy; Signs and Symptoms

• Registration Number: ISRCTN33222797
• Lead Sponsor: McGill University Health Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-06
• Study Completion: 2016-06-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Included patients will be patients having had cough symptoms for at least 3 months (chronic cough), and that have already been worked up by respirologists to rule out other etiologies of cough. These patients will have failed all other medical therapies: inhaled corticosteroids and single dose of antireflux medication.

Exclusion Criteria

1. Patients without cough symptoms for over 3 months
2. Patients that have not been worked up by a respirologist and who have not attempted inhaled corticosteroids or antireflux medication
3. Patients who have been taking over the counter (OTC) antitussives, or angiotensin converting enzymes inhibitors medication
4. Patients who have been taking antibiotics in the last month for a respiratory tract infection
5. Patients who are smokers (both smoking and recent respiratory tract infection could confound our results)
6. Patients who are pregnant or breast feeding
7. Patients with abnormal hepatic or kidney function tests (creatinine over 100, ALT over 36 U/L, AST over 35 U/L, total bilirubin over 26 mmol/L)
8. Patients with abnormalities on the electrocardiogram that have not been cleared by a cardiologist
9. Patients with significant cardiac, renal, hepatic, epileptic, hematologic antecedents
10. Patients taking anticholinergic or sympathomimetic medications
11. Patients above the age of 70

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the quality of life and symptomatic outcomes of chronic cough patients when treated with amitriptyline (Elavil) vs. gabapentin (Neurontin) therapy as measured by the Leicester cough questionnaire at 10 days, 3 weeks, 6 weeks and 4 months after initiation of treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. To evaluate the side effect profile of this medication when used to treat chronic cough<br> 2. To understand the time line of symptom improvement with each of these agents<br><br> To understand if patients are showing responses to the medication, we will conduct phone interviews at days 10 and 21 after treatment initiation. At this time, we will repeat the Leicester Cough Questionnaire and patients will be asked about presence of different side effects. 6 weeks after the initiation of treatment, patients will be seen in clinic by the laryngologist. At this time, the questionnaire and side effect profile will be repeated for a third time, however the patient will also undergo direct laryngoscopy to assess changes in vocal cord inflammation. The reflux finding score will also be completed.<br><br> These will allow us to evaluate onset of action of each agent, side effect profile, and improvement in quality of life.<br>