Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01404013
First received: July 26, 2011
Last updated: July 11, 2014
Last verified: November 2012
  Purpose

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 Intervention Phase
Asthma
Drug: ICS/LABA
Drug: Montelukast
Drug: ICS/LABA and Montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • Day-time and night-time cough symptom total-score changes from baseline to visit 4 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: ICS/LABA
Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks
Other Name: Symbicort Turbuhaler

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01404013

Contacts
Contact: Kefang Lai, PhD 8620 83062893 klai@163.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 520120
Contact: Kefang Lai, PHD       klai@163.com   
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Mengfeng Li, MD. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01404013     History of Changes
Other Study ID Numbers: MISP 39227
Study First Received: July 26, 2011
Last Updated: July 11, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Symbicort
Budesonide
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Glucocorticoids
Hormones
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014