Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS)
Onset of Action of Advair HFA 115/21 in Comparison to Symbicort pMDI 160/4.5 Measured by Impulse Oscillometry, IOS.
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Sep 2008
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedMarch 24, 2009
March 1, 2009
1 year
March 23, 2009
March 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Integrated low frequency reactance improvement after initial dosing
5, 20, 40, 60, 120, and 240 min
Secondary Outcomes (2)
Frequency-dependence of Resistance (R5-R20) after initial dosing
5, 20, 40, 60, 120, and 240 min
Model-derived estimates of Large and Small Airway Resistance and Compliance, and their changes after initial dosing
5, 20, 40, 60, 120, and 240 min
Study Arms (2)
Advair 115/21 MDI
EXPERIMENTALAdvair HFA 115/21 MDI Intervention = initiate intervention after screening
2 = Symbicort 160/4.5
ACTIVE COMPARATORSymbicort initiated after screening
Interventions
Two puffs from MDI twice daily for 4 weeks
Symbicort 160/4.5 pMDI Two puffs from MDI twice daily for 4 weeks
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of asthma
- Asthma symptoms controlled by short-acting beta agonist as-needed
- Age 12-45 years
You may not qualify if:
- Severe asthma
- use of oral or inhaled corticosteroids within 30 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allergy and Asthma Center of El Pasolead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Allergy and Asthma Center of El Paso
El Paso, Texas, 79925, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rogelio Menendez, MD
Allergy and Asthma Center of El Paso
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 24, 2009
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
March 24, 2009
Record last verified: 2009-03