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)

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00867737
• Other study ID #: CRT112430
• Status: Recruiting
• Phase: Phase 4
• First received: March 23, 2009
• Last updated: March 23, 2009
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2009
• Source: Allergy and Asthma Center of El Paso
• Contact: Rogelio Menendez, MD
• Phone: 915-591-2080
• Email: rmaacep[@]swbell.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Advair HFA MDI 115/21
Two puffs from MDI twice daily for 4 weeks
• Symbicort 160/4.5 pMDI
Symbicort 160/4.5 pMDI Two puffs from MDI twice daily for 4 weeks

Locations

Country	Name	City	State
United States	Allergy and Asthma Center of El Paso	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Allergy and Asthma Center of El Paso	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integrated low frequency reactance improvement after initial dosing		5, 20, 40, 60, 120, and 240 min	No
Secondary	Frequency-dependence of Resistance (R5-R20) after initial dosing		5, 20, 40, 60, 120, and 240 min	No
Secondary	Model-derived estimates of Large and Small Airway Resistance and Compliance, and their changes after initial dosing		5, 20, 40, 60, 120, and 240 min	No