Symbicort Onset of Action 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

April 3, 2009

Start Date ^ICMJE

April 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 NCT00646620 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: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Symbicort Onset of Action 1

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 (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

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

Enrollment ^ICMJE

Completion Date

September 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

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

NCT00646620

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0732, D5896C00732

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Catherine Bonuccelli

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

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