Asthma Biomarkers for Predicting Response to Therapy

NCT01973751 | Unknown

• 2 other identifiers: 8117002230770941
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks

  1. 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. 2. 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

Study Arms (3)

Healthy controls

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.

Asthmatics (treatment)

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.

Drug: Budesonide

Asthmatics (no treatment)

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.

Interventions

Budesonide DRUG

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

Also known as: Pulmicort

Asthmatics (treatment)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Department of Respiratory and Critical Care Medicine, Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

CN (1)