Chitinases and Transforming Growth Factor Beta (TGFB) in Human Asthma

NCT01073410 | Completed

• 2 other identifiers: 10-02173U19AI077439
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the roles of two specific gene families (the chitinase gene family and the TGFB family). We hypothesize that chitinases and TGFb pathway genes will be differentially expressed in the airways of non-asthmatic subjects and subjects with asthma. We further hypothesize that genetic variants in CHIT1, AMCase, and TGFb pathway genes that show associations with asthma and related phenotypes will change the expression and/or function of the protein of these genes in the airway in several ways, including the transcript numbers for full length genes and splice variants and, for the chitinase genes, the levels of chitinase activity in airway secretions.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Expression of CHIT1, AMCase, and TGFb pathway genes in asthma

  Current

Study Arms (2)

Healthy, non-asthmatic controls

People who are non-asthmatic and non-smokers.

Asthmatics

People who have been diagnosed with asthma.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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
• Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs).

You may not qualify if:

• Cigarette smoking: Subjects must be non-smokers. Non smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs.
• Pregnant women
• 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.
• Healthy control subjects must have no history of asthma or allergic rhinitis
• Upper respiratory tract infection in the 4 weeks prior to enrollment in the study

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

sputum, blood, saliva, DNA, RNA, Plasma

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• John G Fahy, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

US (1)