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Open-label Study of the Effects of Montelukast in Patients With Chronic Cough

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ClinicalTrials.gov Identifier: NCT01754220
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

Tracking Information
First Submitted Date  ICMJE November 3, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date December 21, 2012
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ]
  • Difference in average scores on modified Leicester Cough Questionnaire (LCQ) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Difference in pulmonary function parameters (FVC, FEV1, PEF), before and after two weeks of treatment with montelukast [ Time Frame: 7 months ]
  • Difference in Exhaled breath temperature (EBT) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ]
  • Difference in laboratory markers (CBC, CRP, total IgE, ESP, MPO) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study of the Effects of Montelukast in Patients With Chronic Cough
Official Title  ICMJE The Effects of Alvokast (Montelukast) in Patients With Chronic Cough
Brief Summary Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of chronic cough and this could be made objective by measuring cough threshold before and after two weeks of treatment.
Detailed Description

Chronic cough is typically defined as cough that persists for longer than 8 weeks and is the most common presenting symptom in adults who seek medical treatment in an ambulatory setting. Prospective studies have shown that three conditions account for the etiologic cause of chronic cough in the largest part of immunocompetent, nonsmoking patients with normal chest radiograph findings. In order of frequency, they are upper airway cough syndrome (UACS), previously referred to as postnasal drip syndrome (PNDS), asthma and gastroesophageal reflux disease (GERD). UACS comprises many different conditions including PNDS, acute sinusitis, allergic rhinitis, non-allergic rhinitis (postinfectious rhinitis, rhinitis medicamentosa, vasomotor rhinitis, rhinitis due to physical or chemical irritants). Cough occurs in all asthmatics, and in a subset of patients with cough-variant asthma (CVA), it is the only presenting symptom. In these cases it is well controlled with inhaled corticosteroids and beta-2 agonists. GERD is another cause that should be contemplated when anti-tussive or anti-inflammatory/anti-allergic treatment do not render results and when there are presenting symptoms suggestive of it. Moreover, factors like smoking and use of ACE-inhibitors should also be taken into account.

Leukotrienes are very important agents in the inflammatory response. It is known that they are contributing significantly to the pathological processes in asthma. Montelukast is a leukotriene receptor antagonist which blocks the bonding of leukotrienes to their receptors thus inhibiting their inflammatory, bronchoconstrictive and mucosecretory effects. Multiple clinical trials have demonstrated the ability of the leukotriene antagonists to improve symptoms, pulmonary function and bronchial hyperresponsiveness in patients with asthma. However, not much is known about their effects in people with chronic cough. Studies have been carried out in an attempt to find out the effects of montelukast in some forms of chronic cough. Nevertheless, the impact of montelukast on objective parameters such as cough reflex threshold, has not been explored. The investigators also reckon that montelukast will affect exhaled breath temperature - a novel surrogate marker of airway inflammation recognized lately

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coughing
Intervention  ICMJE Drug: Montelukast
Montelukast is a leukotriene receptor antagonist
Other Name: Alvokast
Study Arms  ICMJE Active Comparator: Montelukast
Montelukast tablets: adults - 10 mg, children - 5mg taken daily for two weeks
Intervention: Drug: Montelukast
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with chronic cough: cough persisting for more than 8 consecutive weeks

Exclusion Criteria:

  • Current use of ACE-inhibitors
  • Use of systemic steroids in the last 4 weeks
  • COPD
  • Pregnancy
  • Concomitant severe disease
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754220
Other Study ID Numbers  ICMJE ALKA-03-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Todor Popov, Association Asthma, Bulgaria
Study Sponsor  ICMJE Association Asthma, Bulgaria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todor A Popov, MD, Phd Association Asthma, Bulgaria
PRS Account Association Asthma, Bulgaria
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP