Atlantis Symbicort - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00646594

Purpose

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	Intervention	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Asthma control assessed by asthma exacerbations [ Time Frame: Continuosly throughout the treatment period ]

Secondary Outcome Measures:

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 ]
Use of medical resources and medication for the treatment of asthma. [ Time Frame: Throughout the treatment period ]
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 ]

Estimated Enrollment:	1200
Study Start Date:	November 2003
Study Completion Date:	January 2005

Arms	Assigned Interventions
1: Experimental budesonide/formoterol	Drug: budesonide/formoterol (Symbicort)
2: Active Comparator fluticasone/salmeterol	Drug: fluticasone/salmeterol (Advair)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646594

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mitchell Golmand, MD	AstraZeneca
Study Chair:	Catherine Bonuccelli	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5896C00005
Study First Received:	March 26, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00646594 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma
inhaled cortocisteroids
Symbicort

budesonide/formoterol
Advair
fluticasone/salmeterol

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Symbicort
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive

Tocolytic Agents
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Formoterol
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009