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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01754220
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

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.

Condition or disease Intervention/treatment Phase
Coughing Drug: Montelukast Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Alvokast (Montelukast) in Patients With Chronic Cough
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01754220

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Clinic of Allergy and Asthma, University Hospital "Alexandrovska"
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Association Asthma, Bulgaria
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Principal Investigator: Todor A Popov, MD, Phd Association Asthma, Bulgaria
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Todor Popov, Professor, Association Asthma, Bulgaria Identifier: NCT01754220    
Other Study ID Numbers: ALKA-03-12
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action