Gemini Symbicort pMDI - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00646516

Purpose

The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.

Condition	Intervention	Phase
Mild or Moderate Asthma	Drug: budesonide/formoterol (Symbicort)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Rand, Doubleblind, Activecontrolled, Parallel-Grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over

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 start of treatment in evening pre-dose FEV1 [ Time Frame: 2, 6 and 12 weeks after starting treatment ]

Secondary Outcome Measures:

Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes [ Time Frame: Daily ]
Investigate safety profile of Symbicort and budesonide [ Time Frame: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment ]

Estimated Enrollment:	615
Study Start Date:	October 2003
Study Completion Date:	February 2005

Arms	Assigned Interventions
1: Experimental	Drug: budesonide/formoterol (Symbicort)

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of asthma
Baseline lung function tests as determined by protocol.
Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria:

Severe asthma
Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646516

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Liza O'Dowd, MD	AstraZeneca
Study Chair:	Catherine Bonuccelli	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5896C00001
Study First Received:	March 26, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00646516 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma
inhaled corticosteroids
Symbicort
budesonide/formoterol
budesonide

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 February 08, 2010