Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test
Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 28, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedJanuary 8, 2013
January 1, 2013
1 year
December 28, 2012
January 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
whether there was improvement in pre-challenge FEV1%
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.
from commencement of LTRA therapy to (7±2) days and (56±5) days
Secondary Outcomes (1)
whether there was improvement in post- treatment FENO
from commencement of LTRA therapy to (7±2) days and (56±5) days
Other Outcomes (6)
whether there was improvement in post- treatment PD20FEV1-MCH
from commencement of LTRA therapy to (7±2) days and (56±5) days
whether there was improvement in post- treatment AQLQ symptom score
from commencement of LTRA therapy to (7±2) days and (56±5) days
whether there was improvement in post- treatment ACT score
from commencement of LTRA therapy to (56±5) days
- +3 more other outcomes
Study Arms (2)
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
montelukast, vitamin C pill
montelukast:10 mg, once per night，56 days vitamin C pill:100mg，once per night，56 days
Eligibility Criteria
Bronchial Asthma patients
You may qualify if:
- Aged 15-60 years, male or female.
- Mild to moderate persistent asthma.
- Mini AQLQ score ≤6 or ACQ score ≥1.
- Giving written informed consent.
You may not qualify if:
- Current smoker or quitted smoking ≤12 months.
- Significant allergen exposure.
- Respiratory tract infection within 2 weeks before or during the study.
- Cardiovascular disease.
- History of malignant disease within the preceding 5 years.
- And/or concomitant pulmonary disease.
- Pregnant or breast-feed period.
- Use of leukotrienes receptor antagonist within 5 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Guangzhou Institute of Respiratory Disease
Study Record Dates
First Submitted
December 28, 2012
First Posted
January 3, 2013
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Last Updated
January 8, 2013
Record last verified: 2013-01