Symbicort Onset of Action 1 - Full Text View

Purpose

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Condition	Intervention	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair Diskus) Drug: albuterol (Ventolin)	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Fluticasone propionate Fluticasone Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Budesonide Symbicort Salmeterol Salmeterol xinafoate

U.S. FDA Resources

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

Official Title:	A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

FEV1 3 minutes post dose [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]

Secondary Outcome Measures:

12 hour serial FEV1 [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]
Patients perception of effect [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]

Enrollment:	48
Study Start Date:	April 2003
Study Completion Date:	December 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental budesonide/formoterol	Drug: budesonide/formoterol (Symbicort)
2: Active Comparator fluticasone/salmeterol	Drug: fluticasone/salmeterol (Advair Diskus)
3: Active Comparator albuterol	Drug: albuterol (Ventolin)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of asthma and baseline lung function test results as determined by protocol
Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion Criteria:

Severe asthma or asthma markedly affected by seasonal factors
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646620

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Catherine Bonuccelli	AstraZeneca

More Information

Study ID Numbers:	SD-039-0732, D5896C00732
First Received:	March 26, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00646620
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma

bronchodilatation

Symbicort

budesonide/formoterol

Advair Diskus

Ventolin

Study placed in the following topic categories:

Salmeterol

Symbicort

Albuterol

Budesonide

Asthma

Lung Diseases, Obstructive

Hypersensitivity

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Formoterol

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Anti-Allergic Agents

Reproductive Control Agents

Hormones

Glucocorticoids

Adrenergic Agonists

Pharmacologic Actions

Tocolytic Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00646620