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Symbicort Onset of Action 1

A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00646620
Enrollment
48
Registered
2008-03-28
Start date
2003-04-30
Completion date
2003-09-30
Last updated
2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, bronchodilatation, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin

Brief 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

Interventions

DRUGfluticasone/salmeterol (Advair Diskus)
DRUGalbuterol (Ventolin)

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
FEV1 3 minutes post dose4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary

MeasureTime frame
12 hour serial FEV14 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Patients perception of effect4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026