Efficacy of Pregabalin on Chronic Cough

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482818
• Other study ID #: 2011734-01H
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Ottawa Hospital Research Institute
• Contact: Kayvan Amjadi, MD
• Phone: 613-798-5555
• Email: kamjadi[@]toh.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

A significant number of patients have an impaired quality of life due to chronic cough that fails to respond to therapeutic efforts.

Research suggests that patients with chronic cough may have an oversensitive cough reflex. Reflexes are involuntary responses to nerve stimulation. Since standard cough medicines may not be helpful for treating the oversensitive cough reflex, treatment with neurologically acting agents has been investigated.

Existing work in treatment of cough of unknown etiology has focused on the use of Gabapentin, a compound that acts neurologically that is used in the treatment of epilepsy and pain. A similar drug, Pregabalin, may be a superior medication for this indication. Pregabalin is rapidly absorbed with peak blood concentrations within 1 hour, has an approximate bioavailability of 90%, and is 3 to 10 times more potent than Gabapentin and has no known pharmacokinetic drug interactions.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Pregabalin
Increasing dose regimen depending on tolerability followed by decreasing dose regimen.
• Control-Placebo
A control substance, Lactose is administered in place of Pregabalin.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital (General and Civic Campuses)	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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