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CompletedNCT00652392Updated Jan 24, 2011

Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

A Phase 3 interventional study of budesonide/formoterol and budesonide and placebo in Asthma, sponsored by AstraZeneca. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2011-01-24.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • adolescents
  • adults
  • Symbicort
  • budesonide/formoterol
  • budesonide
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 750 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
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the 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 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    1

    Drug: budesonide/formoterol

  • Placebo comparator
    2

    Drug: budesonide and placebo

Interventions

  • Drugbudesonide/formoterol

    Also known as: Symbicort

  • Drugbudesonide and placebo
06

What researchers measure

Primary outcomes

  1. Change in evening PEF

    Time frame: Daily throughout the 12 week treatment period

Secondary outcomes

  1. Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

    Time frame: Daily throughout the 12 week treatment period

  2. Health-related quality of life

    Time frame: 4 assessments within 12 week treatment period

  3. Routine safety assessments

    Time frame: 4 assessments within 12 week treatment period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte W. Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma. Allergy Asthma Proc. 2010 Jan-Feb;31(1):49-59. doi: 10.2500/aap.2010.31.3309. PubMed 20167145 ↗
09

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 ↗
10

Registry details

Key details

Study ID
NCT00652392
Lead sponsor
AstraZeneca
First posted
Apr 3, 2008
Start date
Apr 2003
Completion
Jun 2004
Last update
Jan 24, 2011

Study contacts

Catherine Bonuccelli
study director · 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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