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

Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test

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.

Study Overview

• Status: Unknown
• Conditions: Bronchial Asthma

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease
      • Contact: Shi Xu, doctor; Phone Number: +8618026250151; Email: shixu1003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bronchial Asthma patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whether there was improvement in pre-challenge FEV1%	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.	from commencement of LTRA therapy to (7±2) days and (56±5) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from commencement of LTRA therapy to (7±2) days and (56±5) days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from commencement of LTRA therapy to (7±2) days and (56±5) days
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.	from commencement of LTRA therapy to (7±2) days and (56±5) days
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.	from commencement of LTRA therapy to (56±5) days
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.	from commencement of LTRA therapy to (56±5) days
improvement in weekly and monthly 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.	from commencement of LTRA therapy to (56±5) days
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.	from commencement of LTRA therapy to (7±2) days and (56±5) days

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: leukotriene; leukotriene receptor antagonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2012BAI05B01