Gemini Symbicort pMDI

Condition(s) targeted: Mild or Moderate Asthma

Intervention: budesonide/formoterol (Symbicort) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Liza O'Dowd, MD, Study Director, Affiliation: AstraZeneca
Catherine Bonuccelli, Study Chair, Affiliation: AstraZeneca

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.

Official title: 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

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

Primary outcome: Change from start of treatment in evening pre-dose FEV1

Secondary outcome:

Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes

Investigate safety profile of Symbicort and budesonide

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: October 2003
Ending date: May 2005
Last updated: March 27, 2008