Asthma Biomarkers for Predicting Response to Therapy

NCT ID: NCT01973751

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-07-31

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy controls

Healthy controls who will be studied at baseline and serve as a control group for the bronchoscopy, induced sputum and peripheral blood collection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Asthmatics (treatment)

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.

Group Type: ACTIVE_COMPARATOR

Budesonide

Intervention Type: DRUG

Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks

Asthmatics (no treatment)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Budesonide

Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Pulmicort

Eligibility Criteria

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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guohua Zhen, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Respiratory and Critical Care Medicine, Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

30770941

Identifier Type: -

Identifier Source: secondary_id

81170022

Identifier Type: -

Identifier Source: org_study_id