Status:
COMPLETED
Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA)
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: Therapeutic outcomes of leukotriene receptor antagonist (LTRA) vary in asthmatics，and there's not an ideal and simple way for prediction at present. Objective：To investigate whether leuko...
Detailed Description
Our primary goal was to determine whether LTD4-BPT could be a clear indicator for assessing efficacy of LTRA. Logistic regression model was adopted for statistical analysis. In this model, pre-treatme...
Eligibility Criteria
Inclusion
- subjects aged between 18 and 65，without acute upper respiratory tract infection for the past 2 weeks
- had a normal chest radiographic result
- had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted
- had withheld leukotriene receptor antagonists (LTRA) for over 5 days
- oral glucocorticosteroid or anti-histamine for 3 days
- oral xanthenes or long-acting bronchodilators for 2 days
- inhaled corticosteroid or long-acting bronchodilator for a day as well as short-acting bronchodilator for 4 hours prior to the measurement
Exclusion
- subjects had a fall of no less than 15% in FEV1 after repetitive forced respiration or a fall of no less than 20% in FEV1 after the inhalation of ethanol diluent control
- had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）
- had a poor cooperation to the test or limited understandings, were immunocompromised, or had participated other clinical trials for the past 3 months.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01414868
Start Date
March 1 2010
End Date
September 1 2010
Last Update
August 18 2011
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120