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Titratable Dosing in Moderate to Severe Asthmatics

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00651768
First received: April 1, 2008
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.


Condition Intervention Phase
Asthma
 Drug: budesonide/formoterol
Drug: Symbicort pMDI + budesonide HFA pMDI
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. [ Time Frame: 7 assessments within 12 month treatment period ]

Secondary Outcome Measures:
  • To measure changes in lung function tests, patient reported outcomes and usage of medical resource [ Time Frame: 7 assessments within 12 month treatment period ]
  • Blood levels of budesonide and formoterol [ Time Frame: 10 blood samples taken at 1 visit in a sub-set of patients ]

Estimated Enrollment: 570
Study Start Date: August 2003
Study Completion Date: January 2005
Arms Assigned Interventions
Experimental: 1 Drug: budesonide/formoterol
Other Name: Symbicort
Sham Comparator: 2 Drug: Symbicort pMDI + budesonide HFA pMDI
Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
  • Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651768

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00651768     History of Changes
Other Study ID Numbers: SD-039-0728, D5896C00728
Study First Received: April 1, 2008
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
asthma
adults
adolescents
safety
 Symbicort
budesonide/formoterol
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013