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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867737

Enrollment

Registered

2009-03-24

Start date

2008-09-30

Completion date

2009-09-30

Last updated

2009-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Forced Oscillation, Impulse Oscillometry, Electrical-equivalent respiratory system model

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.

Detailed description

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.

Interventions

DRUGAdvair HFA MDI 115/21

Two puffs from MDI twice daily for 4 weeks

DRUGSymbicort 160/4.5 pMDI

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Integrated low frequency reactance improvement after initial dosing	5, 20, 40, 60, 120, and 240 min

Secondary

Measure	Time frame
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

Countries

United States

Contacts

Primary ContactRogelio Menendez, MD

rmaacep@swbell.net915-591-2080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026