Efficacy of Pregabalin on Chronic Cough
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|ClinicalTrials.gov Identifier: NCT02482818|
Recruitment Status : Unknown
Verified September 2020 by Ottawa Hospital Research Institute.
Recruitment status was: Recruiting
First Posted : June 26, 2015
Last Update Posted : September 25, 2020
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|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 :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 84 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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
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 email@example.com|
|Contact: Nha Voduc, MD||613-737-8899 ext firstname.lastname@example.org|
|The Ottawa Hospital (General and Civic Campuses)||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Isabelle Seguin 613-737-8811 email@example.com|
|Principal Investigator: Kayvan Amjadi, MD|
|Sub-Investigator: Nha Voduc, MD|
|Principal Investigator:||Kayvan Amjadi, MD||Ottawa Hospital Research Institute|
|Responsible Party:||Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||June 26, 2015 Key Record Dates|
|Last Update Posted:||September 25, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
cough reflex sensitivity
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Central Nervous System Depressants