Role of microRNAs in T Cell-Driven Inflammation in Asthma (RITA)
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|ClinicalTrials.gov Identifier: NCT01484691|
Recruitment Status : Recruiting
First Posted : December 2, 2011
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Budesonide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Role of miRNAs in Th2-driven Inflammation in Asthma|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
No Intervention: Healthy non-asthmatic controls
Healthy non-asthmatic controls who will be studied at one point in time and serve as a control group for the baseline bronchoscopy and evaluation of T-cell miRNA expression.
Active Comparator: Asthmatics (treatment)
Steroid-naïve asthma (randomized to 8 weeks of treatment with inhaled corticosteroids). Asthmatics not on inhaled corticosteroids, randomized to inhaled budesonide, 1 puff (180mcg) twice a day for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline (before corticosteroids) and again after treatment with inhaled corticosteroids.
Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Other Name: Pulmicort
No Intervention: Asthmatics (no treatment)
Steroid-naïve asthma (randomized to 8 weeks of no inhaled corticosteroid treatment). Asthmatics not on inhaled corticosteroids, randomized to no change in treatment for 8-10 weeks. These subjects will undergo bronchoscopy and T-cell miRNA measurement at baseline and again after 8 weeks without treatment with inhaled corticosteroids.
- Change from baseline of T cell miRNA expression at 1 week [ Time Frame: 1 week ]Identification of T cell miRNAs which are differentially expressed in asthma as compared to healthy controls. We will measure a panel of ~200 miRNAs by qPCR (yielding normalized copy numbers for each miR) and identify differential expressed based on a false discovery rate <0.05.
- Change from baseline of T cell miRNA expression at 8 weeks [ Time Frame: 8 weeks ]Identification of T cell miRNAs which normalized by 8 weeks of treatment with inhaled corticosteroids in asthma (as compared to an untreated group). We will measure the same miRNAs by qPCR as identified in the other Primary Outcome (1 week time frame) and define normalization by treatment as a significant difference between change from 0 to 8 weeks in the corticosteroid treated group as compared to the untreated group (false discovery rate <0.05).
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): NCT01484691
|Contact: Christine P Nguyen, BSemail@example.com|
|Contact: Bobby J Antalek, MS, MPHfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Prescott G Woodruff, MD, MPH||University of California, San Francisco|