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Bronchial AsthmaNCT01414868

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

A study testing leukotriene receptor antagonist (montelukast) in people with Bronchial Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bronchial Asthma
What is being tested?
leukotriene receptor antagonist (montelukast)
How many people
32 participants
Where
1 siteChina
Study dates
Mar 2010to Sep 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

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

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.

Read the 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.

Being tested
leukotriene receptor antagonist (montelukast)
Keywords
Leukotriene, leukotriene receptor antagonist, bronchial provocation test, therapeutic outcome
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leukotriene receptor antagonist (montelukast)Drug

    Also called singulair

    montelukast (10 mg, once per night)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. the days without using salbutamol

    This was a quantitative parameter

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

  11. monthly PEFR

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2011 (estimated)
  2. Study startMar 2010
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01414868
Sponsor's protocol ID
LTD4-BPT20110806
Status last verified
Dec 2009
First submitted
8 Aug 2011
Last updated
18 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24506412

Questions about this trial

What is this clinical trial studying?

A study testing leukotriene receptor antagonist (montelukast) in people with Bronchial Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

whether there was improvement in weekly PEFR (time frame: from commencement of LTRA therapy to (28±7) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011; AzTrials last refreshed its copy on 30 Oct 2026.

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