Gemini Symbicort pMDI

January 21, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

615

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: budesonide/formoterol (Symbicort)
Other Names:
  • Symbicort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes
Time Frame: Daily
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
Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Liza O'Dowd, MD, AstraZeneca
  • Study Chair: Catherine Bonuccelli, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5896C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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