Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA)

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 leukotriene D4 bronchial provocation test (LTD4-BPT) could be an indicator of actual therapeutic outcome of LTRA.

Methods：A single centre, open-labeled trial was performed in 32 asthmatics with positive LTD4-BPT result for a month. All subjects were categorized according to airway responsiveness to leukotriene D4（PD20FEV1-LTD4）. Subjects received montelukast therapy (10mg, once per night), and reassessment was performed (3~5) days after withholding LTRA. The primary end-point was the difference in monthly PEFR. Secondary endpoints included the difference in FENO, PD20FEV1-LTD4, PD20FEV1-MCh, pre-test FEV1, ACT score, AQLQ symptom score, week 4 PEFmax and PEFmin as compared with week 1, gradual decrease in the use of salbutamol and the days without using salbutamol.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Institute of Respiratory Disease
• Treatments: Leukotriene Antagonists; Montelukast

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.