Titratable Dosing in Moderate to Severe Asthmatics - Full Text View

Sponsored by:	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

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
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

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
1: Experimental	Drug: budesonide/formoterol
2: Sham Comparator	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

Study ID Numbers:	SD-039-0728, D5896C00728
Study First Received:	April 1, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00651768 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma
adults
adolescents
safety

Symbicort
budesonide/formoterol
budesonide

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Symbicort
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones

Glucocorticoids
Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

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

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009