Gemini Symbicort pMDI - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 26, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from start of treatment in evening pre-dose FEV1 [ Time Frame: 2, 6 and 12 weeks after starting treatment ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00646516 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes [ Time Frame: Daily ]
Investigate safety profile of Symbicort and budesonide [ Time Frame: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Gemini Symbicort pMDI

Official Title ^ICMJE

A Rand, Doubleblind, Activecontrolled, Parallel-Grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over

Brief Summary

The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Mild or Moderate Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol (Symbicort)

Study Arms / Comparison Groups

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

615

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of asthma
Baseline lung function tests as determined by protocol.
Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria:

Severe asthma
Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Gender

Both

Ages

12 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

NCT00646516

Responsible Party

Study ID Numbers ^ICMJE

D5896C00001

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Liza O'Dowd, MD	AstraZeneca
Study Chair:	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