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Trial record 3 of 544 for:    RITA

Role of microRNAs in T Cell-Driven Inflammation in Asthma (RITA)

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ClinicalTrials.gov Identifier: NCT01484691
Recruitment Status : Active, not recruiting
First Posted : December 2, 2011
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Prescott Woodruff, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE December 2, 2011
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01484691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of microRNAs in T Cell-Driven Inflammation in Asthma
Official Title  ICMJE Role of miRNAs in Th2-driven Inflammation in Asthma
Brief Summary This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms of asthma through detailed molecular analysis of airway tissues and fluids. The primary goal will be investigate the role of microRNAs in Th2-driven inflammation in asthma. The investigators hypothesize that asthma is associated with abnormal expression of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven inflammation and that abnormalities in T cell miRNA expression will be most prominent in a subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers that the investigators have previously established). Finally, the investigators hypothesize that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also facilitate the pursuit of secondary analyses designed to investigate mechanisms of inflammation and remodeling in asthma as well as molecular phenotypes of asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Budesonide
Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Other Name: Pulmicort
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Budesonide
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Group A:

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 70 years

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 in the past 6 weeks
  • Hyperreactivity to methacholine (PC20FEV1 Methacholine ≤ 8.0 mg/mL)
  • At least one of the following symptoms, beta agonist use, or FEV1 criteria:

    • Asthma symptoms on at least two days per week; OR
    • Beta agonist use on at least two days per week; OR
    • FEV1 < 85% predicted

Groups A & B:

Exclusion Criteria:

  • Current smokers (smoking within the last 12 months) or former smokers who have a total pack-year smoking history greater than 10
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484691
Other Study ID Numbers  ICMJE 11-07039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prescott Woodruff, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Prescott G Woodruff, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP