Gemini Symbicort pMDI

AstraZeneca615 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

615

Conditions

Mild or Moderate Asthma

Interventions

budesonide/formoterol (Symbicort)DRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from start of treatment in evening pre-dose FEV1

Time frame: 2, 6 and 12 weeks after starting treatment

Secondary Outcomes

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

Data from ClinicalTrials.gov

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