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

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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

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:	October 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Show 58 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Tomas LG Andersson )
Study ID Numbers:	D589BL00003
Study First Received:	June 19, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00702325
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Formoterol
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Glucocorticoids
Hormones
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009