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Chronic cough treatment: the McGill experience

The McGill experience with Chronic Cough Treatment: A Phase 2 Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33222797
Enrollment
100
Registered
2015-01-06
Start date
2014-12-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic cough secondary to irritable larynx and post-viral neuropathy Signs and Symptoms

Interventions

Recruitment of patients (N=100) from our regular clinical activities, on 3 different sites: Montreal General hospital, Royal Victoria hospital, Jewish General hospital. Patients who meet the inclusion

Sponsors

McGill University Health Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To evaluate the side effect profile of this medication when used to treat chronic cough 2. To understand the time line of symptom improvement with each of these agents 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. These will allow us to evaluate onset of action of each agent, side effect profile, and improvement in quality of life.

Countries

Canada

Contacts

Public ContactEmily Kay-Rivest

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026