Atlantis Symbicort

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00646594
First received: March 26, 2008
Last updated: March 26, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
Experimental: 1
budesonide/formoterol
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
fluticasone/salmeterol
Drug: fluticasone/salmeterol (Advair)
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00646594     History of Changes
Other Study ID Numbers: D5896C00005
Study First Received: March 26, 2008
Last Updated: March 26, 2009
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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Formoterol
Salmeterol
Albuterol
Symbicort
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014