Asthma Biomarkers for Predicting Response to Therapy

Tongji Hospital

Status: Unknown

Conditions: Asthma

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT01973751

30770941

81170022

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 3 patient groups

Healthy controls

No Intervention group

Description:

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

Asthmatics (treatment)

Active Comparator group

Description:

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.

Treatment:

Drug: Budesonide

Asthmatics (no treatment)

No Intervention group

Description:

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.