Cough
Conditions
Keywords
chronic cough, cough hypersensitivity, Lyrica, Pregabalin, cough reflex sensitivity
Brief 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).
Detailed 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.
Interventions
DRUGPregabalin
Increasing dose regimen depending on tolerability followed by decreasing dose regimen.
DRUGControl-Placebo
A control substance, Lactose is administered in place of Pregabalin.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire) | 42 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of pregabalin on cough reflex sensitivity, which can be objectively measured using citric acid cough challenge | 42 days | 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. |
Countries
Canada
Contacts
Primary ContactKayvan Amjadi, MD
Backup ContactNha Voduc, MD
Outcome results
None listed