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

Guangzhou Institute of Respiratory Disease

Status: Unknown

Conditions: Bronchial Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT01759472

2012BAI05B01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

montelukast，vitamin C pill

Description:

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

montelukast, vitamin C pill

Description:

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