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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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
Experimental: 1 budesonide/formoterol	Drug: budesonide/formoterol (Symbicort) Other Name: Symbicort
Active Comparator: 2 fluticasone/salmeterol	Drug: fluticasone/salmeterol (Advair Diskus) Other Name: Advair Diskus
Active Comparator: 3 albuterol	Drug: albuterol (Ventolin) Other Name: 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

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

Keywords provided by AstraZeneca:

asthma
bronchodilatation
Symbicort

budesonide/formoterol
Advair Diskus
Ventolin

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Formoterol
Salmeterol
Budesonide
Fluticasone
Symbicort

Fluticasone, salmeterol drug combination
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012