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Symbicort Onset of Action 2

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 (Drug); fluticasone/salmeterol (Drug); albuterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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

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

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, Primary Purpose: Treatment

Primary outcome: FEV1 3 minutes post dose

Secondary outcome:

12 hour serial FEV1

Patients perception of effect

Eligibility

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

Criteria:

Inclusion Criteria:

- At least 18 years of age

- Diagnosis of asthma and baseline lung function test results as determined by the

protocol

- Required and received inhaled corticosteroids within timeframe and doses specified in

the protocol Exclusion Criteria:

- Severe asthma or asthma that is markedly effected by seasonal factors

- Has required and received non-inhaled corticosteroids within the previous 4 weeks,

has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Locations and Contacts

Additional Information

Starting date: March 2003
Last updated: January 21, 2011

Page last updated: August 23, 2015

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