NCT00187499

Brief Summary

The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone) alters the expression of any gene expressed in the lining of the airways of asthmatics. The study uses high density gene chips which allow the study investigators to measures all gene in the human genome. We hypothesize that this approach will identify novel genes that are affected by steroids in asthmatics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

April 3, 2008

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

April 2, 2008

Conditions

Asthma

Keywords

AsthmaCorticosteroidGene expression

Outcome Measures

Primary Outcomes (1)

  • Methacholine responsiveness

Secondary Outcomes (2)

  • gene expression in brushed epithelial cells

  • lung function

Interventions

Inhaled fluticasone 500 ug BID for 8 weeksDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with a history of asthma between the ages of 18 and 70 years.
  • 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 \< 15 packs).

You may not qualify if:

  • History of oral or inhaled steroid use in the past 4 weeks.
  • FEV1 \< 60% predicted.
  • Lung disease other than asthma.
  • Patients with a history of a respiratory tract infection in the 4 weeks preceding the study.
  • Patients who have experienced a significant exacerbation in their asthma in the 6 weeks prior to the study.
  • Patients receiving hyposensitization therapy with the exception of those who are on a stable dose for the last three months.
  • Patients with cardiovascular disease (active) peptic ulcer disease or diabetes mellitus.
  • Females who are lactating or who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Airway Clinical Research Center, Room 1303 Moffitt, UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • John V Fahy, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2002

Study Completion

February 1, 2005

Last Updated

April 3, 2008

Record last verified: 2005-09

Locations

US(1)