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)

NCT ID: NCT00867737

Last Updated: 2009-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advair 115/21 MDI

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

Group Type: EXPERIMENTAL

Advair HFA MDI 115/21

Intervention Type: DRUG

Two puffs from MDI twice daily for 4 weeks

2 = Symbicort 160/4.5

Symbicort initiated after screening

Group Type: ACTIVE_COMPARATOR

Symbicort 160/4.5 pMDI

Intervention Type: DRUG

Symbicort 160/4.5 pMDI

Two puffs from MDI twice daily for 4 weeks

Interventions

Advair HFA MDI 115/21

Two puffs from MDI twice daily for 4 weeks

Intervention Type: DRUG

Symbicort 160/4.5 pMDI

Symbicort 160/4.5 pMDI

Two puffs from MDI twice daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Advair = fluticasone proprionate plus salmeterol; Symbicort = budesonide plus formoterol fumarate

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Allergy and Asthma Center of El Paso

OTHER

Sponsor Role: lead

Responsible Party

Allergy and Asthma Center of El Paso

Principal Investigators

Rogelio Menendez, MD

Role: PRINCIPAL_INVESTIGATOR

Allergy and Asthma Center of El Paso

Locations

Allergy and Asthma Center of El Paso

El Paso, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rogelio Menendez, MD

Role: CONTACT

rmaacep@swbell.net

915-591-2080

Facility Contacts

Rogelio Menendez, MD

Role: primary

rmaacep@swbell.net

915-591-2080

Other Identifiers

CRT112430

Identifier Type: -

Identifier Source: org_study_id