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Symbicort Onset of Action 1

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: budesonide/formoterol (Symbicort) (Drug); fluticasone/salmeterol (Advair Diskus) (Drug); albuterol (Ventolin) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Bonuccelli, Study Director, Affiliation: AstraZeneca


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

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: FEV1 3 minutes post dose

Secondary outcome:

12 hour serial FEV1

Patients perception of effect


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: April 2003
Last updated: April 3, 2009

Page last updated: August 23, 2015

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