The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity

NCT00453765 | Completed Phase 4 DMC

• 1 other identifier: NL14828.075.06
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to determine whether montelukast during 6 weeks has superior antitussive effects (measured with the LCQ) compared with placebo in patients with cough lasting \> 8 weeks and enhanced bronchial hyperreactivity.

Conditions

Cough; Bronchial Hyperreactivity

Keywords

cough; hyperreactivity; montelukast

Outcome Measures

Primary Outcomes (1)

• Difference in average score on the Leicester Cough Questionnaire (LCQ) between the two treatment groups; montelukast vs placebo.

  2 years

Secondary Outcomes (2)

• Difference in cough VAS scores; montelukast vs placebo.

  2 years

• Comparison of the adverse events of montelukast vs placebo.

  2 years

Study Arms (2)

A

EXPERIMENTAL

montelukast

Drug: montelukast

B

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

montelukast DRUG

montelukast, 8 weeks, once daily, 10 milligrams

Also known as: singulair

A

placebo DRUG

placebo

B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients between 18 and 90 years old, referred to the cough outpatient clinic with chronic cough and enhanced bronchial hyperreactivity.
• chronic cough is defined as a cough \> 8 weeks duration.
• enhanced bronchial hyperreactivity is a PD20 \< 2.5 mg methacholine.

You may not qualify if:

• concomitant severe disease; lung cancer and diseases with a short life expectancy (\< 1 year).
• patients suffering from COPD and/or other relevant lung diseases.
• clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
• use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 courses during the last 6 months.
• pregnancy.
• abnormal chest X-ray.
• use of medication inducing CYP3A4 (for example; fenytoïne, phenobarbital or rifampicin.
• use of medication metabolised by CYP2C8.

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Cough; Bronchial Hyperreactivity

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Willem Van Den Berg, MD

  Departement of Pulmonology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

NL (1)