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RECRUITING
NCT01225913
PHASE4

Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Sponsor: Gelb, Arthur F., M.D.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists. The investigators are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. The investigators are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation. The investigators are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma.

Official title: Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers

Key Details

Gender

All

Age Range

10 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2007-10

Completion Date

2027-06

Last Updated

2023-10-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

fluticasone/salmeterol in all asthmatics

budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days

DRUG

budesonide/formoterol or fluticasone/salmeterol in all asthmatics

budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid

Locations (1)

Arthur F Gelb Medical Corporation

Lakewood, California, United States