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

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01073410
First received: February 19, 2010
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Chitinases and TGFB in Human Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Expression of CHIT1, AMCase, and TGFb pathway genes in asthma [ Time Frame: Current ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

sputum, blood, saliva, DNA, RNA, Plasma


Estimated Enrollment: 45
Study Start Date: February 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy, non-asthmatic controls
People who are non-asthmatic and non-smokers.
Asthmatics
People who have been diagnosed with asthma.

Detailed Description:

This is a cross-sectional study in patients with asthma and healthy controls in which we will analyze how the expression or function of CHIT1, AMCase, and TGFb pathway genes in the asthmatic airway is affected by genetic variation in these genes. We propose detailed phenotyping of the asthmatic subjects and the healthy controls, including collection of induced sputum, exhaled air and detailed physiologic measures including measures of airflow, lung volumes, and methacholine responsiveness as well as collection of airway cells and tissues by bronchoscopy. We will determine the relative expression of CHIT1 and AMCase in specific lung compartments (large airways, small airways, epithelial cells, macrophages) and the effects of genetic variants in CHIT1 and AMCase on expression of splice variants and levels of chitinase activity in the airway. These human samples will also allow us to determine if any of the multiple TGFb pathway genes analyzed show differential expression in the lung in asthma.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073410

Contacts
Contact: Christine Nguyen, BS 415-476-3824 christine.nguyen@ucsf.edu

Locations
United States, California
UCSF Airway Clinical Research Center Recruiting
San Francisco, California, United States, 94143
Contact: Christine Nguyen, BS    415-476-3824    christine.nguyen@ucsf.edu   
Principal Investigator: Prescott G Woodruff, MD, MPH         
Sub-Investigator: John V Fahy, MD, MSc         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Prescott G Woodruff, MD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01073410     History of Changes
Other Study ID Numbers: H6788-32208
Study First Received: February 19, 2010
Last Updated: January 21, 2014
Health Authority: United States: UCSF Committee on Human Research

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014