Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-Dose Inhaler (pMDI) or Oxis Turbuhaler
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stable Asthma
Intervention: budesonide/formoterol (Drug); formoterol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Michael E Ruff, MD, Study Director, Affiliation: Pharmaceutical Research & Consulting Inc
Catherine Bonuccelli, Study Chair, Affiliation: AstraZeneca
Summary
The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort
with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.
Clinical Details
Official title: A Randomized, Multicenter, Open-Label, Active-Controlled, Single-Dose, 5-Period, Incomplete Block, Cross-Over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety Study
Primary outcome: Average FEV1 during 12 hours
Secondary outcome: Urine levels of formoterol in 2 different formulationsSafety profiles of formoterol in 2 different formulations
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 18 years of age
- Diagnosis of asthma and baseline lung function tests as determined by the protocol
- Required and received treatment with inhaled corticosteroids within timeframe and
doses specified in the protocol
Exclusion Criteria:
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks,
has sensitivity to drugs specified in protocol or requires treatment with
beta-blockers
Locations and Contacts
Additional Information
Starting date: October 2002
Ending date: July 2003
Last updated: April 8, 2008
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