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

Coughing Clinical Trial

Official title:

The Effects of Alvokast (Montelukast) in Patients With Chronic Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754220
• Other study ID #: ALKA-03-12
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2012
• Last updated: December 18, 2012
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Association Asthma, Bulgaria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ethics committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coughing

Intervention

Drug:
• Montelukast
Montelukast is a leukotriene receptor antagonist

Locations

Country	Name	City	State
Bulgaria	Clinic of Allergy and Asthma, University Hospital "Alexandrovska"	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Association Asthma, Bulgaria

Country where clinical trial is conducted

Bulgaria, 

References & Publications (2)

Palombini BC, Villanova CA, Araújo E, Gastal OL, Alt DC, Stolz DP, Palombini CO. A pathogenic triad in chronic cough: asthma, postnasal drip syndrome, and gastroesophageal reflux disease. Chest. 1999 Aug;116(2):279-84. — View Citation

Paredi P, Caramori G, Cramer D, Ward S, Ciaccia A, Papi A, Kharitonov SA, Barnes PJ. Slower rise of exhaled breath temperature in chronic obstructive pulmonary disease. Eur Respir J. 2003 Mar;21(3):439-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast		7 months	Yes
Primary	Difference in average scores on modified Leicester Cough Questionnaire (LCQ) before and after two weeks of treatment with montelukast		7 months	Yes
Secondary	Difference in pulmonary function parameters (FVC, FEV1, PEF), before and after two weeks of treatment with montelukast		7 months	Yes
Secondary	Difference in Exhaled breath temperature (EBT) before and after two weeks of treatment with montelukast		7 months	Yes
Secondary	Difference in laboratory markers (CBC, CRP, total IgE, ESP, MPO) before and after two weeks of treatment with montelukast		7 months	Yes