- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414868
Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- The First Affiliated Hospital of Guangzhou Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from commencement of LTRA therapy to (28±7) days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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from commencement of LTRA therapy to (28±7) days
|
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.
|
from commencement of LTRA therapy to (28±7) days
|
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.
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from commencement of LTRA therapy to (28±7) days
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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.
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from commencement of LTRA therapy to (28±7) days
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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.
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from commencement of LTRA therapy to (28±7) days
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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.
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from commencement of LTRA therapy to (28±7) days
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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.
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from commencement of LTRA therapy to (28±7) days
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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.
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from commencement of LTRA therapy to (28±7) days
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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.
|
from commencement of LTRA therapy to (28±7) days
|
the days without using salbutamol
Time Frame: from commencement of LTRA therapy to (28±7) days
|
This was a quantitative parameter
|
from commencement of LTRA therapy to (28±7) days
|
monthly PEFR
Time Frame: from commencement of LTRA therapy to (28±7) days
|
This was a quantitative parameter, which was expressed as percentage.
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from commencement of LTRA therapy to (28±7) days
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
- Leukotriene Antagonists
Other Study ID Numbers
- LTD4-BPT20110806
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