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)

March 23, 2009 updated by: Allergy and Asthma Center of El Paso

Onset of Action of Advair HFA 115/21 in Comparison to Symbicort pMDI 160/4.5 Measured by Impulse Oscillometry, IOS.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79925
        • Recruiting
        • Allergy and Asthma Center of El Paso
        • Contact:
        • Principal Investigator:
          • Rogelio Menendez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Advair 115/21 MDI
Advair HFA 115/21 MDI Intervention = initiate intervention after screening
Drug: Advair HFA MDI 115/21
Two puffs from MDI twice daily for 4 weeks
Other Names:
  • Advair = fluticasone proprionate plus salmeterol
ACTIVE_COMPARATOR: 2 = Symbicort 160/4.5
Symbicort initiated after screening
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency-dependence of Resistance (R5-R20) after initial dosing
Time Frame: 5, 20, 40, 60, 120, and 240 min
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
Time Frame: 5, 20, 40, 60, 120, and 240 min
5, 20, 40, 60, 120, and 240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergy and Asthma Center of El Paso

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Rogelio Menendez, MD, Allergy and Asthma Center of El Paso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (ESTIMATE)

March 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2009

Last Update Submitted That Met QC Criteria

March 23, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT112430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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