Efficacy of Pregabalin on Chronic Cough
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|ClinicalTrials.gov Identifier: NCT02482818|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Pregabalin Drug: Control-Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||May 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
Placebo Comparator: Control-Placebo
Administration of Placebo (Lactose instead of Pregabalin) pills in an increasing dose regimen followed by a decreasing dose regimen over 35 days during a 42 day trial.
Initially an increasing dosage of placebo (Lactose) will be administered. On Visit 1 an increasing dose (25 mg twice a day for 3 days, then 50 mg twice a day for 2 days and then 75 mg twice a day for 2 days).
Eight days after initial placebo administration, following an assessment by the Doctor of how well subjects are doing on their (drug or placebo), the study placebo will be increased to 100 mg twice a day.
Twenty eight days after initial placebo administration subjects will begin to receive the study placebo in a reducing dose regimen for 7 days then follow up at day 42.
A control substance, Lactose is administered in place of Pregabalin.
Other Name: Lactose Pills.
Administration of Pregabalin in an increasing dose regimen followed by a decreasing dose regimen over 35 days during a 42 day trial.
Initially an increasing dosage of Pregabalin will be administered. On Visit 1 an increasing dose (25 mg twice a day for 3 days, then 50 mg twice a day for 2 days and then 75 mg twice a day for 2 days).
Eight days after initial medication administration, following an assessment by the Doctor of how well subjects are doing on the medication, the study medication will be increased to 100 mg twice a day.
Twenty eight days after initial drug administration subjects will begin to receive the study medication in a reducing dose regimen for 7 days.
Forty two days after initial drug administration the Doctor will meet with subjects to follow up.
Increasing dose regimen depending on tolerability followed by decreasing dose regimen.
- Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire) [ Time Frame: 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
- Evaluate the impact of pregabalin on cough reflex sensitivity, which can be objectively measured using citric acid cough challenge [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482818
|Contact: Kayvan Amjadi, MD||613-798-5555 ext firstname.lastname@example.org|
|Contact: Nha Voduc, MD||613-737-8899 ext email@example.com|
|The Ottawa Hospital (General and Civic Campuses)||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Isabelle Seguin 613-737-8811 firstname.lastname@example.org|
|Principal Investigator: Kayvan Amjadi, MD|
|Sub-Investigator: Nha Voduc, MD|
|Principal Investigator:||Kayvan Amjadi, MD||Ottawa Hospital Research Institute|