CoughPhase 1/2NCT02482818
Efficacy of Pregabalin on Chronic Cough
A Phase 1/2 study testing Pregabalin in people with Cough, run by Ottawa Hospital Research Institute at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cough
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital (General and Civic Campuses)
Ottawa, Ontario, K1Y 4E9
Isabelle Seguin, 613-737-8811, iseguin@ohri.ca
Kayvan Amjadi, MD
About this study
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).
Read the 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.
- Conditions
- Cough
- Being tested
- Pregabalin, Control-Placebo
- Keywords
- chronic cough, cough hypersensitivity, Lyrica, Pregabalin, cough reflex sensitivity
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Increasing dose regimen depending on tolerability followed by decreasing dose regimen.
Control-PlaceboDrug
Also called Lactose Pills.
A control substance, Lactose is administered in place of Pregabalin.
| Study group | Role | What they receive |
|---|---|---|
| Control-Placebo | Placebo comparator | 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. Receives: Drug: Control-Placebo |
| Pregabalin | Experimental | 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. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 42 days
Secondary outcomes (1)
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.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayvan Amjadi, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482818
- Sponsor's protocol ID
- 2011734-01H
- Status last verified
- Sep 2020
- First submitted
- 8 Feb 2015
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02482818
- Acronym / sponsor ID
- 2011734-01H
- Conditions
- Cough
- Keywords
- chronic cough, cough hypersensitivity, Lyrica, Pregabalin, cough reflex sensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Placebo | Placebo comparator | Drug: Control-PlaceboAdministration 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. |
| Pregabalin | Experimental | Drug: PregabalinAdministration 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinIncreasing dose regimen depending on tolerability followed by decreasing dose regimen. | Drug | Pregabalin |
| Control-PlaceboAlso: Lactose Pills.A control substance, Lactose is administered in place of Pregabalin. | Drug | Control-Placebo |
Primary outcome
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
1 secondary outcome
Evaluate the impact of pregabalin on cough reflex sensitivity, which can be objectively measured using citric acid cough challenge
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayvan Amjadi, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pregabalin in people with Cough, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kayvan Amjadi, MD (613-798-5555 ext. 18139, kamjadi@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire) (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.