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) - Full Text View

Sponsor:	Allergy and Asthma Center of El Paso
Collaborator:	GlaxoSmithKline
Information provided by:	Allergy and Asthma Center of El Paso
ClinicalTrials.gov Identifier:	NCT00867737

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Advair HFA MDI 115/21 Drug: Symbicort 160/4.5 pMDI	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Onset of Action of Advair HFA 115/21 in Comparison to Symbicort pMDI 160/4.5 Measured by Impulse Oscillometry, IOS.

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Formoterol fumarate Formoterol Advair Symbicort

U.S. FDA Resources

Further study details as provided by Allergy and Asthma Center of El Paso:

Primary Outcome Measures:

Integrated low frequency reactance improvement after initial dosing [ Time Frame: 5, 20, 40, 60, 120, and 240 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency-dependence of Resistance (R5-R20) after initial dosing [ Time Frame: 5, 20, 40, 60, 120, and 240 min ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Advair 115/21 MDI: Experimental 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
2 = Symbicort 160/4.5: Active Comparator Symbicort initiated after screening	Drug: Symbicort 160/4.5 pMDI Symbicort 160/4.5 pMDI Two puffs from MDI twice daily for 4 weeks

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.

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867737

Contacts

Contact: Rogelio Menendez, MD

915-591-2080

rmaacep@swbell.net

Locations

United States, Texas
Allergy and Asthma Center of El Paso	Recruiting
El Paso, Texas, United States, 79925
Contact: Rogelio Menendez, MD 915-591-2080 rmaacep@swbell.net
Principal Investigator: Rogelio Menendez, MD

Sponsors and Collaborators

Allergy and Asthma Center of El Paso

GlaxoSmithKline

Investigators

Principal Investigator:

Rogelio Menendez, MD

Allergy and Asthma Center of El Paso

More Information

No publications provided

Responsible Party:	Allergy and Asthma Center of El Paso ( Rogelio Menendez, MD/Principal Investigator )
Study ID Numbers:	CRT112430
Study First Received:	March 23, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00867737 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Allergy and Asthma Center of El Paso:

Asthma
Forced Oscillation
Impulse Oscillometry
Electrical-equivalent respiratory system model

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010