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Asthma Biomarkers for Predicting Response to Therapy

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Respiratory and Critical Care Medicine, Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Healthy controls

Asthmatics (treatment)

Asthmatics (no treatment)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2013
Last Updated
May 13, 2016
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01973751
Brief Title
Asthma Biomarkers for Predicting Response to Therapy
Official Title
Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
Healthy controls who will be studied at baseline and serve as a control group for the bronchoscopy, induced sputum and peripheral blood collection.
Arm Title
Asthmatics (treatment)
Arm Type
Active Comparator
Arm 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.
Arm Title
Asthmatics (no treatment)
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pulmicort
Intervention Description
Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Respiratory and Critical Care Medicine, Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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Asthma Biomarkers for Predicting Response to Therapy

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