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Completed

NCT Number: NCT01414868

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

leukotriene receptor antagonist (montelukast)

Drug

montelukast (10 mg, once per night)

Other names: singulair

Primary outcomes

  1. whether there was improvement in weekly PEFR

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

    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 outcomes

  1. whether there was improvement in post- treatment FENO

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

    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.

  2. whether there was improvement in post- treatment PEF max

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

    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.

  3. whether there was improvement in post- treatment PEF min

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

    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.

  4. whether there was improvement in post- treatment PD20FEV1-LTD4

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

    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.

  5. whether there was improvement in post- treatment PD20FEV1-MCh

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

    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.

  6. whether there was improvement in post- treatment AQLQ symptom score

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

    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.

  7. whether there was improvement in post- treatment ACT score

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

    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.

  8. whether there was improvement in pre-challenge FEV1

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

    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.

  9. whether there was a gradual decrease in weekly use of salbutamol

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

    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.

  10. the days without using salbutamol

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

    This was a quantitative parameter

  11. monthly PEFR

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

    This was a quantitative parameter, which was expressed as percentage.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

Could Leukotriene D4 Bronchial Provocation Test be a Clear Indicator for Predicting Therapeutic Outcomes of Leukotriene Receptor Antagonist A Pilot Study

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2011
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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