Status:
UNKNOWN
Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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: ...
Detailed Description
Study groups: 99 patients diagnosed with CVA will be randomised into three groups as follows: Group 1: inhaled corticosteroid+β2 agonist The patients with cough variant asthma received Symbicort Tur...
Eligibility Criteria
Inclusion
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment\* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
Exclusion
- Patients demonstrate FEV1/FVC \<70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- 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.
- 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.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- Subjects who have received any therapy in the previous seven days, e.g. oral/ inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
- 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.
- Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01404013
Start Date
February 1 2012
End Date
August 1 2014
Last Update
July 14 2014
Active Locations (1)
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1
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China, 520120