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

NCT01414868 | Completed

• 1 other identifier: LTD4-BPT20110806
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bronchial Asthma

Keywords

Leukotriene; leukotriene receptor antagonist; bronchial provocation test; therapeutic outcome

Outcome Measures

Primary Outcomes (1)

• whether there was improvement in weekly PEFR

  The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).PEFR was defined as the changed rate of peak expiratory flow, which was calculated using the formula according to maximal PEF (PEFmax) and minimal PEF (PEFmin) measured by portable PEF monitor: 100%\*(PEFmax-PEFmin)/\[(PEFmax+PEFmin)\*1/2\]. A higher PEFR is more suggestive of instability of asthma control.

  from commencement of LTRA therapy to (28±7) days

Secondary Outcomes (11)

• whether there was improvement in post- treatment FENO

  from commencement of LTRA therapy to (28±7) days

• whether there was improvement in post- treatment PEF max

  from commencement of LTRA therapy to (28±7) days

• whether there was improvement in post- treatment PEF min

  from commencement of LTRA therapy to (28±7) days

• whether there was improvement in post- treatment PD20FEV1-LTD4

  from commencement of LTRA therapy to (28±7) days

• whether there was improvement in post- treatment PD20FEV1-MCh

  from commencement of LTRA therapy to (28±7) days

Interventions

leukotriene receptor antagonist (montelukast) DRUG

montelukast (10 mg, once per night)

Also known as: singulair

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• Guan WJ, Shi X, Zheng JP, Gao Y, Jiang CY, Xie YQ, Liu QX, Zhu Z, Guo E, An JY, Yu XX, Liu WT, Zhong NS. Leukotriene D4 inhalation challenge for predicting short-term efficacy of montelukast: a pilot study. Clin Respir J. 2015 Jan;9(1):111-20. doi: 10.1111/crj.12117. Epub 2014 Mar 5.

  PMID: 24506412 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Leukotriene Antagonists; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 11, 2011
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 18, 2011

Record last verified: 2009-12

Locations

CN (1)