Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

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: NCT01404013
Recruitment Status : Unknown
Verified November 2012 by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : July 27, 2011
Last Update Posted : July 14, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:

This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).

The investigators hypothesize:

  1. Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
  2. Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.

Condition or disease Intervention/treatment Phase
Asthma Drug: ICS/LABA Drug: Montelukast Drug: ICS/LABA and Montelukast Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Leukotriene Modulator Montelukast Alone or Combined With Inhaled Corticosteroid on Cough Variant Asthma
Study Start Date : February 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Cough Steroids
Drug Information available for: Montelukast

Arm Intervention/treatment
Active Comparator: Montelukast
Monotherapy with Montelukast 10mg, take orally ,every night,for 8 weeks
Drug: Montelukast
Montelukast 10mg ,every night, for 8 weeks
Other Name: Singulair

Active Comparator: ICS/LABA and Montelukast
Combination therapy with inhaled corticosteroid/β2 agonist 160/4.5ug,twice a day and Montelukast 10mg,take orally,every night for 8 weeks
Drug: ICS/LABA and Montelukast
Budesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks
Other Names:
  • Inhaled corticosteroid/β2 agonist: Symbicort Turbuhaler
  • Montelukast: Singulair

Active Comparator: ICS/LABA
Monotherapy with corticosteroid/β2 agonist 160/4.5ug,inhaled, twice a day, for 8 weeks
Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks
Other Name: Symbicort Turbuhaler

Primary Outcome Measures :
  1. Day-time and night-time cough symptom total-score changes from baseline to visit 4 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Cough reflex sensitivity changes in different groups at baseline, visit 2, visit3, and visit 4. Cell differential changes in hypertonic saline induced sputum in different groups at baseline, visit 2, visit3, and visit 4. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
  2. Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
  3. There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
  4. Patients whose chest x-ray outcome was normal or without any active focus.
  5. Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).

Exclusion Criteria:

  1. Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
  2. Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
  3. Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
  4. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
  5. Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
  6. Subjects who have received any therapy in the previous seven days, e.g. oral/ inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
  7. Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
  8. Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.

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): NCT01404013

Contact: Kefang Lai, PhD 8620 83062893

China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 520120
Contact: Kefang Lai, PHD   
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Merck Sharp & Dohme Corp.
Study Chair: Mengfeng Li, MD. Sun Yat-sen University

Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University Identifier: NCT01404013     History of Changes
Other Study ID Numbers: MISP 39227
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: November 2012

Keywords provided by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University:
Cough variant asthma
Inhaled Corticosteroid

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
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