Symbicort Onset of Action 1 - Full Text View

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair Symbicort Arformoterol Tartrate Levalbuterol tartrate

U.S. FDA Resources

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:	September 2003

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

No publications provided

Study ID Numbers:	SD-039-0732, D5896C00732
Study First Received:	March 26, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00646620 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma
bronchodilatation
Symbicort

budesonide/formoterol
Advair Diskus
Ventolin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Symbicort
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Formoterol
Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009