Efficacy of Pregabalin on Chronic Cough

NCT02482818 | Unknown Phase 1 DMC

• 1 other identifier: 2011734-01H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cough

Keywords

chronic cough; cough hypersensitivity; Lyrica; Pregabalin; cough reflex sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  42 days

Secondary Outcomes (1)

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

  42 days

Study Arms (2)

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.

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.

Drug: Pregabalin

Interventions

Pregabalin DRUG

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

Pregabalin

Control-Placebo DRUG

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

Also known as: Lactose Pills.

Control-Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital (General and Civic Campuses)

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Cough; Chronic Cough

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kayvan Amjadi, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayvan Amjadi, MD

CONTACT

613-798-5555; kamjadi@toh.on.ca

Nha Voduc, MD

CONTACT

613-737-8899; nvoduc@toh.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: June 26, 2015
• Study Start: September 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

CA (1)