Atlantis Symbicort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646594
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 27, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : November 2003
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
Drug: fluticasone/salmeterol (Advair)
Other Name: Advair

Primary Outcome Measures :
  1. Asthma control assessed by asthma exacerbations [ Time Frame: Continuosly throughout the treatment period ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646594

Sponsors and Collaborators
Study Director: Mitchell Golmand, MD AstraZeneca
Study Chair: Catherine Bonuccelli AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00646594     History of Changes
Other Study ID Numbers: D5896C00005
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
inhaled cortocisteroids

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action