Symbicort Rapihaler Therapeutic Equivalence Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00536731

Purpose

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Condition	Intervention	Phase
Bronchial Asthma	Drug: Symbicort Turbuhaler Drug: Symbicort pMDI Drug: Pulmicort Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 6-Week, Phase III, Double-Blind, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective is to show that Symbicort pMDI 40/2.25 μg two actuations b.i.d is more efficacious than Pulmicort Turbuhaler 100 μg one inhalation b.i.d. over a 6-week treatment period.

Secondary Outcome Measures:

Secondary objectives are to compare the efficacy of Symbicort pMDI 40/2.25 μg two actuations b.i.d with that of Symbicort Turbuhaler 80/4.5 μg one inhalation b.i.d and to investigate the safety profile of Symbicort pMDI 40/2.25 μg two actuations b.i.d,

Estimated Enrollment:	600
Study Start Date:	September 2007
Study Completion Date:	April 2008

Eligibility

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

Criteria

Inclusion Criteria:

· · Asthma clinically diagnosed since at least 6 months.
Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.

Exclusion Criteria:

· Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.

Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536731

Show 51 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson	AstraZeneca
Principal Investigator:	Akos Somoskovi	AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00536731 History of Changes
Other Study ID Numbers:	D5897C00003
Study First Received:	September 27, 2007
Last Updated:	March 26, 2009
Health Authority:	Hungary: National Institute of Pharmacy (OGYI); Poland: Office for Registration of Medicinal Products; Czech Republic: State Institute for Drug Control; Bulgaria: Bulgarian Drug Agency (BDA)

Keywords provided by AstraZeneca:

Asthma
Symbicort

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Symbicort
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012