Symbicort Rapihaler Therapeutic Equivalence Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 27, 2007

Last Updated Date

March 26, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00536731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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,

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Symbicort Rapihaler Therapeutic Equivalence Study

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bronchial Asthma

Intervention ^ICMJE

Drug: Symbicort Turbuhaler
Drug: Symbicort pMDI
Drug: Pulmicort Turbuhaler

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

600

Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Czech Republic, Hungary, Poland

Administrative Information

NCT ID ^ICMJE

NCT00536731

Responsible Party

Study ID Numbers ^ICMJE

D5897C00003

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP