Efficacy of Pregabalin on Chronic Cough

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Pregabalin

Control-Placebo

About this trial

This is an interventional treatment trial for Cough focused on measuring chronic cough, cough hypersensitivity, Lyrica, Pregabalin, cough reflex sensitivity

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ottawa Hospital (General and Civic Campuses)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control-Placebo

Pregabalin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02482818

First Posted

February 8, 2015

Last Updated

September 23, 2020

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02482818

Brief Title

Efficacy of Pregabalin on Chronic Cough

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 Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

Keywords

chronic cough, cough hypersensitivity, Lyrica, Pregabalin, cough reflex sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control-Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Pregabalin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Intervention Description

Increasing dose regimen depending on tolerability followed by decreasing dose regimen.

Intervention Type

Drug

Intervention Name(s)

Control-Placebo

Other Intervention Name(s)

Lactose Pills.

Intervention Description

A control substance, Lactose is administered in place of Pregabalin.

Primary Outcome Measure Information:

Title

Determine the impact of pregabalin on a cough specific quality of life questionnaire (Leicester Cough Questionnaire)

Description

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

Time Frame

42 days

Secondary Outcome Measure Information:

Title

Evaluate the impact of pregabalin on cough reflex sensitivity, which can be objectively measured using citric acid cough challenge

Description

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.

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kayvan Amjadi, MD

Phone

613-798-5555

Ext

18139

Email

kamjadi@toh.on.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Nha Voduc, MD

Phone

613-737-8899

Ext

78198

Email

nvoduc@toh.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kayvan Amjadi, MD

Organizational Affiliation

Ottawa Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital (General and Civic Campuses)

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle Seguin

Phone

613-737-8811

Email

iseguin@ohri.ca

First Name & Middle Initial & Last Name & Degree

Kayvan Amjadi, MD

First Name & Middle Initial & Last Name & Degree

Nha Voduc, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Cough

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial