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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier:
NCT01754220
First received: November 3, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Coughing
Drug: Montelukast
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Alvokast (Montelukast) in Patients With Chronic Cough

Resource links provided by NLM:


Further study details as provided by Association Asthma, Bulgaria:

Primary Outcome Measures:
  • Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Difference in average scores on modified Leicester Cough Questionnaire (LCQ) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in pulmonary function parameters (FVC, FEV1, PEF), before and after two weeks of treatment with montelukast [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Difference in Exhaled breath temperature (EBT) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Difference in laboratory markers (CBC, CRP, total IgE, ESP, MPO) before and after two weeks of treatment with montelukast [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
Montelukast tablets: adults - 10 mg, children - 5mg taken daily for two weeks
Drug: Montelukast
Montelukast is a leukotriene receptor antagonist
Other Name: Alvokast

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

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754220

Locations
Bulgaria
Clinic of Allergy and Asthma, University Hospital "Alexandrovska"
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Association Asthma, Bulgaria
Investigators
Principal Investigator: Todor A Popov, MD, Phd Association Asthma, Bulgaria
  More Information

Publications:
Responsible Party: Prof. Todor Popov, Professor, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier: NCT01754220     History of Changes
Other Study ID Numbers: ALKA-03-12
Study First Received: November 3, 2012
Last Updated: December 18, 2012
Health Authority: Bulgaria: Ethics committee

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014