Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
This study is currently recruiting participants.
Verified November 2012 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborator:
Merck
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: November 15, 2012
Last verified: November 2012
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Purpose
This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid on cough variant asthma.
The investigators hypothesize:
- Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist, and two combinations.
- 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: inhaled corticosteroid/β2 agonist Monotherapy Drug: Inhaled corticosteroid/β2 agonist Combination Therapy |
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: | April 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Monotherapy
Monotherapy with inhaled corticosteroid/β2 agonist
|
Drug: inhaled corticosteroid/β2 agonist Monotherapy
Budesonide 160µg and Formoterol 4.5µg, 1puff Q12h for 8 weeks
Other Name: Symbicort Turbuhaler
|
|
Active Comparator: Combination therapy
Combination therapy with inhaled corticosteroid/β2 agonist
|
Drug: Inhaled corticosteroid/β2 agonist Combination Therapy
Budesonide 160µg and Formoterol 4.5µg,1puff Q12h for 8 weeks; Montelukast 10mg QN for 8 weeks
Other Names:
|
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:
- 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 Criteria:
- 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.
Contacts and Locations
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
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: | November 15, 2012 |
| 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 May 16, 2013