Asthma Biomarkers for Predicting Response to Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01973751|
Recruitment Status : Unknown
Verified May 2016 by Guohua Zhen, MD, Tongji Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 31, 2013
Last Update Posted : May 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Budesonide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
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.
Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks
Other Name: 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.
- Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973751
|Department of Respiratory and Critical Care Medicine, Tongji Hospital|
|Wuhan, Hubei, China, 430030|