Cough Clinical Trial
Official title:
Efficacy of Pregabalin on Chronic Cough: A Double Blind, Randomized Control Trial Comparing Pregabalin With Placebo in Patients With Non-asthmatic Chronic Cough
The purpose of this study is to determine if Pregabalin, a medication used for the treatment of seizures and chronic pain, can be used to effectively treat people who suffer from non-asthmatic chronic cough (cough lasting over 8 weeks).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 84 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of non-asthmatic chronic cough defined as a cough experienced for a period of at least 8 weeks - Negative methacholine challenge (within past year) - Chest x-ray with absence of gross abnormality that could justify the cough or be a cause for the cough (within past 6 months) - Male or female 18 years or older - Willing and able to limit to 1 or less alcohol beverage per day (example: 360 ml of beer or 330 ml of cooler or 120 ml of wine) Exclusion Criteria: - Concurrent use of Gabapentin or Pregabalin for other indications (seizure disorder, chronic pain) - History of allergy / intolerance or adverse effect with Gabapentin or Pregabalin. - Concurrent use of central nervous system depressants (i.e. opioids or benzodiazepines) - Not able to limit daily alcohol intake as recommended in the inclusion criteria - Creatinine clearance < 60ml/min within past three months - Current Smoker or has been quit less than 8 weeks - Symptoms of post nasal drip - History of gastroesophageal reflux. Only participants with untreated Gastroesophageal Reflux Disease (GERD) or less than 8 weeks of therapy will be excluded. - Symptoms of upper airway cough syndrome - ACE inhibitor use - Allergy to citric acid - Pregnant or nursing women - History of angioedema or congestive heart failure |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital (General and Civic Campuses) | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire) | All patients will be required to fill out the questionnaire in the follow up visits. This questionnaire is validated, reliable and subjective method for assessing the response to therapy | 42 days | |
Secondary | Evaluate the impact of pregabalin on cough reflex sensitivity, which can be objectively measured using citric acid cough challenge | Citric acid has been used extensively in the literature as an effective inhaled compound that can induce cough. The changes in the concentration of citric acid that can cause 2 or 5 consecutive coughs (C2 or C5) has been used to objectively determine the impact of various therapies on cough receptors. | 42 days |
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