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

Sponsor:	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

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).

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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
Study Completion Date:	May 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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00242775 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Asthma

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 04, 2010