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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4,802 Previous Clinical Trials
8,377,972 Total Patients Enrolled
301 Trials studying Asthma
500,602 Patients Enrolled for Asthma
Rogelio Menendez, MDPrincipal InvestigatorAllergy and Asthma Center of El Paso
~2 spots leftby Nov 2025