Asthma Biomarkers for Predicting Response to Therapy

Asthma Clinical Trial

Official title:

Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01973751
• Other study ID #: 81170022
• Secondary ID: 30770941
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: May 13, 2016
• Start date: November 2013
• Est. completion date: July 2016

Study information

• Verified date: May 2016
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
China	Department of Respiratory and Critical Care Medicine, Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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