Gemini Symbicort pMDI

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.

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Key information

Conditions

Mild or Moderate Asthma Asthma Bronchial Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol (Symbicort)

Drug

Other names: Symbicort

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Study completion: 2005
First posted: Mar 28, 2008
Registry last updated: Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed