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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Stable Asthma

Treatments: Drug: budesonide/formoterol; Drug: formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658255

SD-039-0729

D5896C00729

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: budesonide/formoterol

2

Active Comparator group

Treatment:

Drug: formoterol