Phase 1 N=127 Basic Science

Study of the Mechanisms of Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00595153 ↗

Enrolled (actual)

127

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: Gene Expression in Airway Secretions and Tissues — -0.66; 0.54; -0.30 Relative gene expression level

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Pulmicort (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Gene Expression in Airway Secretions and Tissues	-0.66; 0.54; -0.30	—

Summary

The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma. In order to take advantage of the most current scientific expertise, we (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with Genentech will provide the best chance of developing new treatments for asthma.

Eligibility Criteria

Inclusion Criteria

Group C:

Male and female subjects between the ages of 18 and 70 years
History of asthma
Continuous treatment with inhaled corticosteroids for at least the 6-week
Hyperreactivity to methacholine (provocative concentration of methacholine causing a 20% drop in forced expiratory volume in 1 second (PC20 FEV1) Methacholine ≤ 16.0 mg/mL).

Exclusion Criteria

History of asthma
No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6 weeks
Hyperreactivity to methacholine (PC20 FEV1 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
Forced expiratory volume in 1 second (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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00595153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.