DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252863

Purpose

The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.

Condition	Intervention	Phase
Asthma	Drug: Symbicort, used twice daily (b.i.d) and as needed (prn) Drug: Budesonide Turbuhaler 200 µg Drug: Fluticasone Discus 250 µg Drug: Formoterol Turbuhaler 4.5 µg Drug: Terbutaline Turbuhaler 0.5 mg Drug: Salbutamol pressurized metered dose inhaler (pMDI) 100 µg Drug: Salmeterol Discus 50 µg Drug: Budesonide/Formoterol Turbuhaler 160/4.5 µg Drug: Fluticasone/Salmeterol Discus 250/50 µg Drug: Fluticasone/Salmeterol Discus 500/50 µg Drug: Theophylline 200 mg Drug: Theophylline 300 mg Drug: Singulair 10 mg	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Montelukast sodium Montelukast Budesonide Symbicort Salmeterol Salmeterol xinafoate Terbutaline Terbutaline sulfate Theophylline Theophylline sodium glycinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to first severe asthma exacerbation

Secondary Outcome Measures:

Number of severe asthma exacerbations
Mean use of as-needed medication
Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
Prescribed asthma medication during the treatment period
Asthma Control Questionnaire (ACQ)
Patient's satisfaction with the treatment question
Health care contacts
Asthma medication
Time lost from paid and unpaid work
Serious adverse events (SAEs)
Discontinuations due to adverse events (AEs)

Estimated Enrollment:	1600
Study Start Date:	December 2004
Study Completion Date:	October 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.

Exclusion Criteria:

Any other significant lung disease other than asthma
Any disease that might put patients at risk if they participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252863

Show 169 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Heinrich Worth, MD

Klinikum Fürth

More Information

Study ID Numbers:	D5890L00011, DESOLO
Study First Received:	November 14, 2005
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00252863
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Salmeterol
Symbicort
Albuterol
Budesonide
Asthma
Terbutaline
Montelukast
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Formoterol
Theophylline
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Tocolytic Agents
Therapeutic Uses

Dermatologic Agents
Adrenergic beta-Agonists
Immune System Diseases
Sympathomimetics
Anti-Asthmatic Agents
Enzyme Inhibitors
Anti-Allergic Agents
Cardiovascular Agents
Glucocorticoids
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009