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OpenTrials
Completed

NCT Number: NCT00658255

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

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.

Completed

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Key information

Conditions

Stable Asthma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol

Drug

Other names: Symbicort

Formoterol

Drug

Other names: Oxis Turbuhaler

Primary outcomes

  1. Average FEV1 during 12 hours

    Time frame: Once a week for 5 weeks during treatment period

Secondary outcomes

  1. Urine levels of formoterol in 2 different formulations

    Time frame: Once a week (12 hour urine collection) for 5 weeks during treatment period

  2. Safety profiles of formoterol in 2 different formulations

    Time frame: Once a week for 5 weeks during treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Apr 14, 2008
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.