Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Part of paid clinical trials in Lakewood, California.

Sponsor
Gelb, Arthur F., M.D.
Study ID
NCT01225913
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • fluticasone/salmeterol in all asthmatics — DRUG
    budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
  • budesonide/formoterol or fluticasone/salmeterol in all asthmatics — DRUG
    budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid

Study Details

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.

Key Dates

Start date
Oct 31, 2007
Status verified
Oct 2023
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Exhaled nitric oxide [ Time Frame: 20-60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur F Gelb Medical CorporationLakewoodCalifornia90712
Arthur F Gelb, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lakewood, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Arthur F Gelb Medical Corporation· Lakewood, CA

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