Role of microRNAs in T Cell-Driven Inflammation in Asthma

NCT ID: NCT01484691

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Budesonide

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Budesonide

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

Intervention Type: DRUG

Other Intervention Names

Pulmicort

Eligibility Criteria

Inclusion Criteria

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

Group B:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prescott G Woodruff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Related Links

http://acrc.ucsf.edu/

UCSF Airway Clinical Research Center

Other Identifiers

11-07039

Identifier Type: -

Identifier Source: org_study_id