Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Guangzhou Institute of Respiratory Disease
Sponsor:
Information provided by (Responsible Party):
Xu Shi, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT01759472
First received: December 28, 2012
Last updated: January 6, 2013
Last verified: January 2013
  Purpose

To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.

Hypothesis :Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.


Condition
Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test

Resource links provided by NLM:


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

Primary Outcome Measures:
  • whether there was improvement in pre-challenge FEV1% [ Time Frame: from commencement of LTRA therapy to (7±2) days and (56±5) 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).A higher FEV1% 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 (7±2) days and (56±5) 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.


Other Outcome Measures:
  • whether there was improvement in post- treatment PD20FEV1-MCH [ Time Frame: from commencement of LTRA therapy to (7±2) days and (56±5) 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 (7±2) days and (56±5) 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 (56±5) 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 a gradual decrease in weekly use of salbutamol [ Time Frame: from commencement of LTRA therapy to (56±5) 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.

  • improvement in weekly and monthly PEFR [ Time Frame: from commencement of LTRA therapy to (56±5) 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.

  • whether there was improvement in post- treatment PD20FEV1-LTD4 [ Time Frame: from commencement of LTRA therapy to (7±2) days and (56±5) 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.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
montelukast,vitamin C pill
leukotriene receptor antagonist:(montelukast),montelukast (10 mg, once per night),56 days vitamin C pill:100mg,once per night,56 days
montelukast, vitamin C pill
montelukast:10 mg, once per night,56 days vitamin C pill:100mg,once per night,56 days

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Bronchial Asthma patients

Criteria

Inclusion Criteria:

  1. Aged 15-60 years, male or female.
  2. Mild to moderate persistent asthma.
  3. Mini AQLQ score ≤6 or ACQ score ≥1.
  4. Giving written informed consent.

Exclusion Criteria:

  1. Current smoker or quitted smoking ≤12 months.
  2. Significant allergen exposure.
  3. Respiratory tract infection within 2 weeks before or during the study.
  4. Cardiovascular disease.
  5. History of malignant disease within the preceding 5 years.
  6. And/or concomitant pulmonary disease.
  7. Pregnant or breast-feed period.
  8. Use of leukotrienes receptor antagonist within 5 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759472

Contacts
Contact: Shi Xu, doctor +8618026250151 shixu1003@163.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Shi Xu, doctor    +8618026250151    shixu1003@163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
  More Information

No publications provided

Responsible Party: Xu Shi, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT01759472     History of Changes
Other Study ID Numbers: 2012BAI05B01
Study First Received: December 28, 2012
Last Updated: January 6, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangzhou Institute of Respiratory Disease:
leukotriene
leukotriene receptor antagonist

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

ClinicalTrials.gov processed this record on September 22, 2014