- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484691
Role of microRNAs in T Cell-Driven Inflammation in Asthma (RITA)
June 1, 2022 updated by: University of California, San Francisco
Role of miRNAs in Th2-driven Inflammation in Asthma
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Other Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Baseline T Cell miRNA Expression Between Asthmatics and Healthy Controls
Time Frame: Baseline (cross-sectional analysis)
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Identification of T cell miRNAs which are differentially expressed in asthma as compared to healthy controls.
The investigators 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.
Normalized copy numbers from this qPCR experiment were established using the "global mean-normalization" approach as described in the paper by Barbara D'haene et al. entitled "miRNA expression profiling - from reference genes to global mean normalization" published in MicroRNA Expression profiling Methods and Protocols, Springer Verlag, Feb 2011.
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Baseline (cross-sectional analysis)
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Change From Baseline of T Cell miRNA Expression at 8 Weeks in Asthmatics in Response to Inhaled Corticosteroids vs. no Treatment
Time Frame: 8 weeks after randomization to inhaled corticosteroids or no treatment
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Identification of T cell miRNAs which were reduced in asthmatics who were randomized to inhaled corticosteroids as compared to those randomized to no treatment.
The investigators will measure the same miRNAs by qPCR as identified in the other Primary Outcome and define a significant change using a multiple comparison adjusted p-value (false discovery rate <0.05).
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8 weeks after randomization to inhaled corticosteroids or no treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Prescott G Woodruff, MD, MPH, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
October 26, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (Estimate)
December 2, 2011
Study Record Updates
Last Update Posted (Actual)
June 24, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Inflammation
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- 11-07039
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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