Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test

• Conditions: Bronchial Asthma

• Registration Number: NCT01759472
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.

Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-28
• Study First Submitted QC: 2012-12-28
• Status Verified: 2013-01
• Study First Posted: 2013-01-03
• Last Update Submitted: 2013-01-06
• Last Update Posted: 2013-01-08
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 15-60 years, male or female.
2. Mild to moderate persistent asthma.
3. Mini AQLQ score ≤6 or ACQ score ≥1.
4. Giving written informed consent.

Exclusion Criteria

1. Current smoker or quitted smoking ≤12 months.
2. Significant allergen exposure.
3. Respiratory tract infection within 2 weeks before or during the study.
4. Cardiovascular disease.
5. History of malignant disease within the preceding 5 years.
6. And/or concomitant pulmonary disease.
7. Pregnant or breast-feed period.
8. Use of leukotrienes receptor antagonist within 5 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
whether there was improvement in pre-challenge FEV1%	from commencement of LTRA therapy to (7±2) days and (56±5) days	The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control.

Secondary Outcome Measures

Name	Time	Method
whether there was improvement in post- treatment FENO	from commencement of LTRA therapy to (7±2) days and (56±5) days	In Logistic regression model, whether there was improvement shown in post-treatment FENO as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. FENO represented fractional exhaled nitric oxide above.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China