Trial | NCT00867737  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Eligibility criteria include age 12-45 years, with current treatment of asthma with as-needed SABA only; and manifesting an acute response to SABA at screening of 40% or greater improvement in IOS low frequency reactance. After inclusion in the protocol, all subjects will receive active treatment, either with Advair or with Symbicort. Outcome measures will include large and small airway resistance and integrated low-frequency reactance calculated directly from IOS measures, and in addition, Large Airway Resistance, Small Airway Resistance and Small Airway Compliance derived from an electrical equivalent respiratory system model. Analysis of IOS data will be done post-testing by a respiratory physiologist, experienced with use of IOS and its analysis and interpretation, blinded to which treatment each individual received. Electrical-equivalent respiratory system model analyses will be done by a biomedical engineer, blinded to which treatment each individual received.
Study Started
Sep 30
2008
Primary Completion
Sep 30
2009
Anticipated
Study Completion
Sep 30
2009
Anticipated
Last Update
Mar 24
2009
Estimate

Drug Advair HFA MDI 115/21

Two puffs from MDI twice daily for 4 weeks

  • Other names: Advair = fluticasone proprionate plus salmeterol

Drug Symbicort 160/4.5 pMDI

Symbicort 160/4.5 pMDI Two puffs from MDI twice daily for 4 weeks

  • Other names: Symbicort = budesonide plus formoterol fumarate

Advair 115/21 MDI Experimental

Advair HFA 115/21 MDI Intervention = initiate intervention after screening

2 = Symbicort 160/4.5 Active Comparator

Symbicort initiated after screening

Criteria 

Inclusion Criteria:

Clinical diagnosis of asthma
Asthma symptoms controlled by short-acting beta agonist as-needed
Age 12-45 years

Exclusion Criteria:

Severe asthma
use of oral or inhaled corticosteroids within 30 days of screening
No Results Posted