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CompletedNCT00646594Updated Mar 27, 2009

Atlantis Symbicort

A Phase 3 interventional study of budesonide/formoterol (Symbicort) and fluticasone/salmeterol (Advair) in Asthma, sponsored by AstraZeneca. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-03-27.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • inhaled cortocisteroids
  • Symbicort
  • budesonide/formoterol
  • Advair
  • fluticasone/salmeterol
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 1,200 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
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of asthma
  • Baseline lung function tests as determined by protocol
  • Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion criteria

Exclusion Criteria:

  • Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
  • Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    1

    budesonide/formoterol

    Drug: budesonide/formoterol (Symbicort)

  • Active comparator
    2

    fluticasone/salmeterol

    Drug: fluticasone/salmeterol (Advair)

Interventions

  • Drugbudesonide/formoterol (Symbicort)

    Also known as: Symbicort

  • Drugfluticasone/salmeterol (Advair)

    Also known as: Advair

06

What researchers measure

Primary outcomes

  1. Asthma control assessed by asthma exacerbations

    Time frame: Continuosly throughout the treatment period

Secondary outcomes

  1. Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.

    Time frame: Daily and at 1, 3 and 6 months after start of treatmen

  2. Use of medical resources and medication for the treatment of asthma.

    Time frame: Throughout the treatment period

  3. Investigate safety profile of Symbicort compared to Advair

    Time frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154. PubMed 20170333 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00646594
Lead sponsor
AstraZeneca
First posted
Mar 28, 2008
Start date
Nov 2003
Completion
Jan 2005
Last update
Mar 27, 2009

Study contacts

Mitchell Golmand, MD
study director · AstraZeneca
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 Mar 2009. You cannot join it, but the record below documents what was studied.

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