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CompletedNCT00658255Updated Jan 24, 2011

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

A Phase 2 interventional study of budesonide/formoterol and formoterol in Stable Asthma, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-24.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stable Asthma

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Keywords

  • stable asthma
  • adults
  • formoterol
  • Symbicort
  • Oxis Turbuhaler
  • bronchodilation
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 175 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    1

    Drug: budesonide/formoterol

  • Active comparator
    2

    Drug: formoterol

Interventions

  • Drugbudesonide/formoterol

    Also known as: Symbicort

  • Drugformoterol

    Also known as: Oxis Turbuhaler

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00658255
Lead sponsor
AstraZeneca
First posted
Apr 14, 2008
Start date
Oct 2002
Completion
May 2003
Last update
Jan 24, 2011

Study contacts

Michael E Ruff, MD
study director · Pharmaceutical Research & Consulting Inc
Catherine Bonuccelli
study chair · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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