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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Allergy and Asthma Center of El Paso.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Allergy and Asthma Center of El Paso
ClinicalTrials.gov Identifier:
NCT00867737
First received: March 23, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
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 Name: 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 Name: Symbicort = budesonide plus formoterol fumarate

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Rogelio Menendez, MD/Principal Investigator, Allergy and Asthma Center of El Paso
ClinicalTrials.gov Identifier: NCT00867737     History of Changes
Other Study ID Numbers: CRT112430
Study First Received: March 23, 2009
Last Updated: March 23, 2009
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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Symbicort
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on July 20, 2014