Symbicort Onset of Action 2 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 27, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

FEV1 3 minutes post dose [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00646009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

12 hour serial FEV1 [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]
Patients perception of effect [ Time Frame: Patients perception of effect ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Symbicort Onset of Action 2

Official Title ^ICMJE

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.

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol
Drug: fluticasone/salmeterol
Drug: albuterol

Study Arms / Comparison Groups

Experimental: budesonide/formoterol
Active Comparator: fluticasone/salmeterol
Active Comparator: albuterol

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00646009

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0733, D5896C00733

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Catherine Bonuccelli

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP