Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 Mg - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00242775

Purpose

The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol Turbuhaler Drug: Salmeterol/fluticasone Diskus	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort Salmeterol Salmeterol xinafoate Terbutaline Terbutaline sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus as-Needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 Mg/Inhalation as-Needed - a 6-Month, Randomised, Double-Blind, Parallel-Group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to first severe asthma exacerbation

Secondary Outcome Measures:

Number of severe asthma exacerbations
Mild asthma exacerbations
FEV1
Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
Healthcare utilization
Safety (adverse events)
- all variables assessed over the 6 months treatment period

Estimated Enrollment:	2100
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2006

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with asthma since at least 6 months prior to first visit
Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
At least one asthma exacerbation more than one but less than twelve months prior to first visit

Exclusion Criteria:

Respiratory infection affecting asthma within 30 days before first visit
Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
Any significant disease or disorder that may jeopardize the safety of the patient

Additional inclusion and exclusion criteria will be evaluated by the Investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242775

Show 143 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

Publications indexed to this study:

Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. Epub 2007 Oct 1.

Study ID Numbers:	D5890C00002, EurodraCT No. 2004-004905-11, AHEAD
Study First Received:	October 20, 2005
Last Updated:	June 23, 2006
ClinicalTrials.gov Identifier:	NCT00242775
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Asthma

Study placed in the following topic categories:

Salmeterol
Symbicort
Budesonide
Asthma
Terbutaline
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
Adrenergic beta-Agonists
Bronchial Diseases
Immune System Diseases
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009