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

This study has been completed.
Sponsor:
Information provided by:
Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT01414868
First received: August 8, 2011
Last updated: August 17, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention
Bronchial Asthma
Drug: leukotriene receptor antagonist (montelukast)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Could Leukotriene D4 Bronchial Provocation Test be a Clear Indicator for Predicting Therapeutic Outcomes of Leukotriene Receptor Antagonist A Pilot Study

Resource links provided by NLM:


Further study details as provided by Guangzhou Institute of Respiratory Disease:

Primary Outcome Measures:
  • whether there was improvement in weekly PEFR [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • whether there was improvement in post- treatment FENO [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment FENO as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. FENO represented fractional exhaled nitric oxide above.

  • whether there was improvement in post- treatment PEF max [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment PEFmax as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative.

  • whether there was improvement in post- treatment PEF min [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment PEFmin as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative.

  • whether there was improvement in post- treatment PD20FEV1-LTD4 [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment PD20FEV1-LTD4 as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. PD20FEV1-LTD4 referred to as the provocative dosage causing a 20% fall in FEV1 while using Leukotriene D4 as a bronchoprovocant.

  • whether there was improvement in post- treatment PD20FEV1-MCh [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment PD20FEV1-MCh as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. PD20FEV1-MCh referred to as the provocative dosage causing a 20% fall in FEV1 while using methacholine as a bronchoprovocant.

  • whether there was improvement in post- treatment AQLQ symptom score [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment AQLQ symptom score as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. Items with regard to asthma symptoms were extracted from the whole AQLQ score, with the total score of 84. Higher score represented better asthma control.

  • whether there was improvement in post- treatment ACT score [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment ACT score as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure above was qualitative. The total score of ACT was 25, with 5 questions in all. Higher score was indicative of better asthma control.

  • whether there was improvement in pre-challenge FEV1 [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was improvement shown in post-treatment pre-challenge FEV1 as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one.

  • whether there was a gradual decrease in weekly use of salbutamol [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    In Logistic regression model, whether there was a gradual decrease in weekly use of salbutamol as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one.

  • the days without using salbutamol [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    This was a quantitative parameter

  • monthly PEFR [ Time Frame: from commencement of LTRA therapy to (28±7) days ] [ Designated as safety issue: No ]
    This was a quantitative parameter, which was expressed as percentage.


Enrollment: 32
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: leukotriene receptor antagonist (montelukast)
    montelukast (10 mg, once per night)
    Other Name: singulair
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-treatment PD20FEV1-LTD4 represented anticipated efficacy. The median of PD20FEV1-LTD4 was used for classification of asthmatics, with a lower figure representing a better anticipated outcome. Various variables, including the difference in pre- and post- treatment FENO, PEFmax, PEFmin, PEFR, PD20FEV1 and asthma scores, were introduced in the model representing the actual efficacy of LTRA. We aimed to test whether there would be certain parameters that assist prediction of anticipated outcome.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414868

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
  More Information

No publications provided

Responsible Party: Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT01414868     History of Changes
Other Study ID Numbers: LTD4-BPT20110806
Study First Received: August 8, 2011
Last Updated: August 17, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Guangzhou Institute of Respiratory Disease:
Leukotriene
leukotriene receptor antagonist
bronchial provocation test
therapeutic outcome

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014