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Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

Phase 2
Completed
Conditions
Stable Asthma
Interventions
Drug: budesonide/formoterol
Registration Number
NCT00658255
Lead Sponsor
AstraZeneca
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
175
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
2formoterol-
1budesonide/formoterol-
Primary Outcome Measures
NameTimeMethod
Average FEV1 during 12 hoursOnce a week for 5 weeks during treatment period
Secondary Outcome Measures
NameTimeMethod
Urine levels of formoterol in 2 different formulationsOnce a week (12 hour urine collection) for 5 weeks during treatment period
Safety profiles of formoterol in 2 different formulationsOnce a week for 5 weeks during treatment period
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