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)
Recruitment status was Recruiting
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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. |
- Integrated low frequency reactance improvement after initial dosing [ Time Frame: 5, 20, 40, 60, 120, and 240 min ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Rogelio Menendez, MD | 915-591-2080 | rmaacep@swbell.net |
| 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 | |
| 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 Budesonide 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 |
ClinicalTrials.gov processed this record on May 23, 2013