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

Who is this study for? Patients with chronic, stable asthma who are non-smokers
What treatments are being studied? Fluticasone+Salmeterol+Budesonide+Formoterol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 80
Healthy Volunteers: f
View:

• Current non-smoking (\<10 pack yr smoking history)

• Stable, treated asthmatics

• Age 10-80 yr

• post 180ug albuterol by MDI: FEV 1/FVC \< 70% and FEV 1 \<80% predicted

Locations
United States
California
Arthur F Gelb Medical Corporation
RECRUITING
Lakewood
Contact Information
Primary
Arthur F Gelb, MD
afgelb@msn.com
562-633-2204
Time Frame
Start Date: 2007-10
Estimated Completion Date: 2027-06
Participants
Target number of participants: 50
Treatments
Other: Asthma observational study arm
Asthmatics in this arm may be on varying dose of inhaled fluticasone 100-500mcg/salmeterol 50mcg bid via Advair MDI or equivalent dose via Diskus bid or Symbicort (budesonide 80-160mcg/formoterol 4.5mcg bid)or Dulera 100-200mcg mometasone/5 mcg formoterol bid, tiotropium 18mcg capsule daily. This is an observational study and additional pharmacologic intervention may include antibiotic and tapering doses of corticosteroids.
Related Therapeutic Areas
Sponsors
Leads: Gelb, Arthur F., M.D.

This content was sourced from clinicaltrials.gov