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Completed

NCT Number: NCT01484691

Role of microRNAs in T Cell-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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks

Other names: Pulmicort

Primary outcomes

  1. Difference in Baseline T Cell miRNA Expression Between Asthmatics and Healthy Controls

    Time frame: Baseline (cross-sectional analysis)

    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.

  2. 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

    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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Role of miRNAs in Th2-driven Inflammation in Asthma

Acronym: RITA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2011
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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