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

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
leukotriene receptor antagonist (montelukast)
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Asthma focused on measuring Leukotriene, leukotriene receptor antagonist, bronchial provocation test, therapeutic outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical College

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

whether there was improvement in post- treatment FENO
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
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
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
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
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
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
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
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
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
This was a quantitative parameter
monthly PEFR
This was a quantitative parameter, which was expressed as percentage.

Full Information

First Posted
August 8, 2011
Last Updated
August 17, 2011
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT01414868
Brief Title
Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA)
Official Title
Could Leukotriene D4 Bronchial Provocation Test be a Clear Indicator for Predicting Therapeutic Outcomes of Leukotriene Receptor Antagonist A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Leukotriene, leukotriene receptor antagonist, bronchial provocation test, therapeutic outcome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
leukotriene receptor antagonist (montelukast)
Other Intervention Name(s)
singulair
Intervention Description
montelukast (10 mg, once per night)
Primary Outcome Measure Information:
Title
whether there was improvement in weekly PEFR
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Secondary Outcome Measure Information:
Title
whether there was improvement in post- treatment FENO
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment PEF max
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment PEF min
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment PD20FEV1-LTD4
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment PD20FEV1-MCh
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment AQLQ symptom score
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in post- treatment ACT score
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was improvement in pre-challenge FEV1
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
whether there was a gradual decrease in weekly use of salbutamol
Description
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.
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
the days without using salbutamol
Description
This was a quantitative parameter
Time Frame
from commencement of LTRA therapy to (28±7) days
Title
monthly PEFR
Description
This was a quantitative parameter, which was expressed as percentage.
Time Frame
from commencement of LTRA therapy to (28±7) days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24506412
Citation
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.
Results Reference
derived

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

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