Phase4/Symbicort Versus Pulmicort Flexhaler in African Americans - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00702325

Purpose

To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Condition	Intervention	Phase
Asthma	Drug: Budesonide /formoterol fumarate Drug: Budesonide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American 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:

change from baseline in the pre-dose forced expiratory volume in one second (FEV1) averaged over the double-blind treatment period [ Time Frame: at clinical visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AM Peak Expiratory Flow (PEF) [ Time Frame: Daily, across treatment period ] [ Designated as safety issue: No ]
PM Peak Expiratory Flow (PEF) [ Time Frame: Daily, across treatment period ] [ Designated as safety issue: No ]
Spirometry Measures [forced vital capacity (FVC), forced expiratory flow (FEF)] [ Time Frame: at clinical visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Experimental	Drug: Budesonide /formoterol fumarate 160/4.5 μg x 2 actuations twice daily (bid)
2: Active Comparator	Drug: Budesonide inhalation powder 180 μg x 2 inhalations bid

Eligibility

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

Criteria

Inclusion Criteria:

African American (self-reported
Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria:

Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702325

Show 58 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Ubaldo Martin, MD	AstraZeneca
Study Director:	Tomas LG Andersson	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Tomas LG Andersson )
Study ID Numbers:	D589BL00003
Study First Received:	June 19, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00702325 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma

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 September 09, 2009