Clinical trial NCT01484691: Role of microRNAs in T Cell-Driven Inflammation in Asthma
Official title: Role of miRNAs in Th2-driven Inflammation in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-12-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Baseline T Cell miRNA Expression Between Asthmatics and Healthy Controls
timeFrame: Baseline (cross-sectional analysis)
measure: Change From Baseline of T Cell miRNA Expression at 8 Weeks in Asthmatics in Response to Inhaled Corticosteroids vs. no Treatment
timeFrame: 8 weeks after randomization to inhaled corticosteroids or no treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Prescott G Woodruff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: