Recruiting

Advair vs. Symbicort

Sponsor:

Allergy and Asthma Center of El Paso

Code:

NCT00867737

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

Advair HFA MDI 115/21

Symbicort 160/4.5 pMDI

Study Details

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.

Conditions

Asthma

Study ID

NCT00867737

Start date

Sep, 2008

Status verified date

Mar, 2009

Completion date

Sep, 2009

Anticipated

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Advair 115/21 MDI

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

active comparator: 2 = Symbicort 160/4.5

Symbicort initiated after screening

Interventions

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

Primary outcome measure

  • Integrated low frequency reactance improvement after initial dosing [ Time Frame: 5, 20, 40, 60, 120, and 240 min ]

Central Contacts and Locations

Central contacts

Rogelio Menendez, MD

915-591-2080rmaacep@swbell.net

Locations

Allergy and Asthma Center of El Paso

Recruiting

El Paso, Texas, United States, 79925

Contacts

Rogelio Menendez, MD

915-591-2080rmaacep@swbell.net

Principal Investigator:

Rogelio Menendez, MD

More Information

Sponsor

Allergy and Asthma Center of El Paso

Last update posted

Mar 24, 2009

Last verified

Mar, 2009

Keywords

  • Asthma
  • Forced Oscillation
  • Impulse Oscillometry
  • Electrical-equivalent respiratory system model

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Allergy and Asthma Center of El Paso on 2009-03-24.