Overview

This trial is active, not recruiting.

Condition asthma
Treatment budesonide
Sponsor Tongji Hospital
Start date November 2013
End date July 2016
Trial size 148 participants
Trial identifier NCT01973751, 30770941, 81170022

Summary

Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description: This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay of asthma therapy. Only about half of the asthmatic patients have improved lung function after treatment of inhaled corticosteroid. The investigators hypothesize that there are biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of asthmatic patients which could predict the response of asthmatic patients to inhaled corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal treatment for individual asthmatic patient.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Healthy controls who will be studied at baseline and serve as a control group for the bronchoscopy, induced sputum and peripheral blood collection.
(Active Comparator)
Steroid-naïve asthma, randomized to inhaled budesonide, 2 puffs (200mcg) twice a day for 8 weeks. These subjects will undergo bronchoscopy and induced sputum collection at baseline, undergo pulmonary function testing and peripheral blood collection at baseline, 4 and 8 weeks after treatment with inhaled corticosteroids.
budesonide Pulmicort
Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks
(No Intervention)
Steroid-naïve asthmatics randomized to no treatment for 8 weeks. These subjects will undergo bronchoscopy and induced sputum collection at baseline, undergo pulmonary function testing and peripheral blood collection at baseline, 4 and 8 weeks of no treatment.

Primary Outcomes

Measure
Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Group A: Inclusion Criteria: - Male and female subjects between the ages of 18 and 70 years - No respiratory symptoms - Normal spirometric value and methacholine PD20 >2.5mg Group B: Inclusion Criteria: - Male and female subjects between the ages of 18 and 70 years - History of asthma - No use of oral or inhaled corticosteroids for the treatment of asthma - No use of leukotriene antagonist for the treatment of asthma - Hyperreactivity to methacholine (PD20 FEV1 Methacholine < 2.5 mg) and/or ≥12% increase in FEV1 following inhalation of 200μg salbutamol - Asthma symptoms of episodic cough, wheeze and/or breathlessness Exclusion Criteria: - Current or former smokers - Pregnant women - Subjects with a history of lung disease other than asthma - Subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study

Additional Information

Official title Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Tongji Hospital.