Asthma Biomarkers for Predicting Response to Therapy

Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Respiratory and Critical Care Medicine, Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Drug: Budesonide; Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks; Other Names: Pulmicort
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks	The baseline expression of airway epithelial cytokines (IL-25, IL-33, TSLP) and/or Th2 cytokines (IL-4, IL-5, IL-13) in bronchial brushing, bronchial biopsy and peripheral blood in healthy control subjects and asthmatic patients.; Change of forced expiratory volume of the 1st second (FEV1) and accumulated dosage of methacholine provoking a 20% fall of in forced expiratory volume in the first second (FEV1 PD20) of asthmatic patients after treatment with inhaled budesonide or non-intervention for 4 and 8 weeks.	8 weeks

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: 81170022; 30770941