Titratable Dosing in Moderate to Severe Asthmatics - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00651768

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 III

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

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

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 February 12, 2012