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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Single-centre, Double Blind Randomised Trial of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity

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.

Detailed Summary:

Chronic cough is a frequent problem in general practice and one of the most common reasons for referral to a respiratory clinic. Prospective studies have shown that the vast majority of cases of chronic cough are due to one or more of three conditions: rhinitis/postnasal drip syndrome, asthma and gastro-oesophageal reflux disease. Other significant causes of chronic cough include postviral (post-infectious) cough, and eosinophilic bronchitis. In only a minority of the patients with a chronic cough no cause can be found. This is called idiopathic cough.

Analysis and treatment of patients with chronic cough often proved to be difficult and disappointing. Nevertheless, centers in which a comprehensive diagnostic and therapeutic protocol was implemented reported excellent results. Therefore the first cough clinic is started in The Isala Klinieken, Zwolle/The Netherlands in 2004.

Asthmatic cough is often accompanied by the more typical symptoms of dyspnoea and wheezing. In a subgroup of asthmatics, however, cough is the sole or predominant symptom. This condition is termed cough-variant asthma (CVA). Cough due to CVA usually improves within the first week of inhaled bronchodilator therapy, however, complete resolution of cough may require up to 8 weeks of combination therapy with inhaled bronchodilators and corticosteroids. A subgroup of CVA patients with severe, refractory cough may require systemic (oral) steroids, alone or followed by inhaled therapy.

Leukotrienes are contributing significantly to the pathobiology of asthma. These 'pathways of asthma' could be suppressed by leukotriene inhibitors. Multiple clinical trials have demonstrated the ability of the leukotriene modifiers to improve symptoms, pulmonary function and bronchial hyperresponsiveness in chronic asthma, as w
Sponsor: Isala

Current Primary Outcome: Difference in average score on the Leicester Cough Questionnaire (LCQ) between the two treatment groups; montelukast vs placebo. [ Time Frame: 2 years ]

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

Current Secondary Outcome:

  • Difference in cough VAS scores; montelukast vs placebo. [ Time Frame: 2 years ]
  • Comparison of the adverse events of montelukast vs placebo. [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Difference in cough VAS scores; montelukast vs placebo.
  • Comparison of the adverse events of montelukast vs placebo.


Information By: Isala

Dates:
Date Received: March 28, 2007
Date Started: December 2007
Date Completion:
Last Updated: April 5, 2013
Last Verified: April 2013