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OpenTrials
Completed

NCT Number: NCT00646594

Atlantis Symbicort

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive 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 within timeframe and doses specified in protocol

Exclusion criteria

  • Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a 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

fluticasone/salmeterol (Advair)

Drug

Other names: Advair

Primary outcomes

  1. Asthma control assessed by asthma exacerbations

    Time frame: Continuosly throughout the treatment period

Secondary outcomes

  1. Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.

    Time frame: Daily and at 1, 3 and 6 months after start of treatmen

  2. Use of medical resources and medication for the treatment of asthma.

    Time frame: Throughout the treatment period

  3. Investigate safety profile of Symbicort compared to Advair

    Time frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.

Important dates

Study start
2003
Study completion
2005
First posted
Mar 28, 2008
Registry last updated
Mar 27, 2009

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.

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