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CompletedNCT00646620Updated Apr 6, 2009

Symbicort Onset of Action 1

A Phase 3 interventional study of budesonide/formoterol (Symbicort) and fluticasone/salmeterol (Advair Diskus) in Asthma, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-06.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • bronchodilatation
  • Symbicort
  • budesonide/formoterol
  • Advair Diskus
  • Ventolin
03

In context

Asthma

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

This study's enrollment of 48 is below 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

  • Diagnosis of asthma and baseline lung function test results as determined by protocol
  • Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion criteria

Exclusion Criteria:

  • Severe asthma or asthma markedly affected by seasonal factors
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    1

    budesonide/formoterol

    Drug: budesonide/formoterol (Symbicort)

  • Active comparator
    2

    fluticasone/salmeterol

    Drug: fluticasone/salmeterol (Advair Diskus)

  • Active comparator
    3

    albuterol

    Drug: albuterol (Ventolin)

Interventions

  • Drugbudesonide/formoterol (Symbicort)

    Also known as: Symbicort

  • Drugfluticasone/salmeterol (Advair Diskus)

    Also known as: Advair Diskus

  • Drugalbuterol (Ventolin)

    Also known as: Ventolin

06

What researchers measure

Primary outcomes

  1. FEV1 3 minutes post dose

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary outcomes

  1. 12 hour serial FEV1

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

  2. Patients perception of effect

    Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

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 Apr 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00646620
Lead sponsor
AstraZeneca
First posted
Mar 28, 2008
Start date
Apr 2003
Completion
Sep 2003
Last update
Apr 6, 2009

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 Apr 2009. You cannot join it, but the record below documents what was studied.

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