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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Study Completion Date:	September 2009

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

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:	Tomas LG Andersson, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00702325 History of Changes
Other Study ID Numbers:	D589BL00003
Study First Received:	June 19, 2008
Last Updated:	November 11, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma

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 09, 2012