Symbicort Onset of Action 2

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00646009

First received: March 26, 2008

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

January 21, 2011

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol
Other Name: Symbicort
Drug: fluticasone/salmeterol
Other Name: Advair Diskus
Drug: albuterol
Other Name: Ventolin

Study Arm (s)

Experimental: 1
budesonide/formoterol

Intervention: Drug: budesonide/formoterol
Active Comparator: 2
fluticasone/salmeterol

Intervention: Drug: fluticasone/salmeterol
Active Comparator: 3
albuterol

Intervention: Drug: albuterol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2003

Primary Completion Date

Not Provided

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

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00646009

Other Study ID Numbers ^ICMJE

SD-039-0733, D5896C00733

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Catherine Bonuccelli

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2011

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

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