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

NCT ID: NCT01759472

Last Updated: 2013-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Brief Summary

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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

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Conditions

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Bronchial Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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montelukast,vitamin C pill

leukotriene receptor antagonist:(montelukast),montelukast (10 mg, once per night),56 days vitamin C pill:100mg,once per night,56 days

No interventions assigned to this group

montelukast, vitamin C pill

montelukast:10 mg, once per night,56 days vitamin C pill:100mg,once per night,56 days

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Xu Shi

Guangzhou Institute of Respiratory Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shi Xu, doctor

Role: CONTACT

+8618026250151

Facility Contacts

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Shi Xu, doctor

Role: primary

+8618026250151

Other Identifiers

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2012BAI05B01

Identifier Type: -

Identifier Source: org_study_id

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