Gemini Symbicort pMDI

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

NCT00646516•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 1, 2003

Completion Date

February 1, 2005

Last Updated

January 24, 2011

Enrollment

615

ESTIMATED participants

Conditions

Mild or Moderate Asthma

Interventions

budesonide/formoterol (Symbicort)

DRUG