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Corticosteroid and Long-Acting Beta Agonist Combination

Advair 115/21 MDI for Asthma

Phase 4
Waitlist Available
Led By Rogelio Menendez, MD
Research Sponsored by Allergy and Asthma Center of El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5, 20, 40, 60, 120, and 240 min
Awards & highlights

Study Summary

The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with asthma extensively at baseline in patients with mild-to-moderate asthma, treated with as-needed short acting beta agonist only, to measure respiratory resistance and small airway dysfunction accurately and precisely at baseline, from which to measure onset of action of Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS resistance and small airway dysfunction and its response to short acting beta agonist (SABA). Patients will be selected from among those who manifest a 40% improvement in small airway function assessed by IOS low frequency reactance after SABA compared to baseline. After screening, patients will be randomized to receive either Advair or Symbicort; and will be assessed at randomization before and at several intervals after initial dosing, up to 4 hours. Patients will return again 4 weeks after randomization for extended IOS (and spirometry) testing as done at randomization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5, 20, 40, 60, 120, and 240 min
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5, 20, 40, 60, 120, and 240 min for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Integrated low frequency reactance improvement after initial dosing
Secondary outcome measures
Frequency-dependence of Resistance (R5-R20) after initial dosing
Model-derived estimates of Large and Small Airway Resistance and Compliance, and their changes after initial dosing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Advair 115/21 MDIExperimental Treatment1 Intervention
Advair HFA 115/21 MDI Intervention = initiate intervention after screening
Group II: 2 = Symbicort 160/4.5Active Control1 Intervention
Symbicort initiated after screening

Find a Location

Who is running the clinical trial?

Allergy and Asthma Center of El PasoLead Sponsor
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,658 Total Patients Enrolled
295 Trials studying Asthma
416,533 Patients Enrolled for Asthma
Rogelio Menendez, MDPrincipal InvestigatorAllergy and Asthma Center of El Paso

Frequently Asked Questions

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~2 spots leftby Apr 2025