Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Budesonide, Formoterol Fumarate Drug Combination; Montelukast

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.