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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Average FEV1 during 12 hours

Secondary outcome:

Urine levels of formoterol in 2 different formulations

Safety 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
Last updated: January 21, 2011

Page last updated: August 23, 2015

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