Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 11, 2005

Last Updated Date

March 16, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Morning peak expiratory flow (mPEF)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00252785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
Safety:
Adverse events (nature, incidence and severity)
Haematology, clinical chemistry and urinalysis
12-lead ECGs, blood pressure, pulse rate
- all variables assessed over the 8 week treatment period

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Official Title ^ICMJE

An 8-Week, Randomised, Double Blind, Parallel-Group, Multi-Centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma

Brief Summary

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Budesonide/Formoterol
Drug: Budesonide
Drug: Theophylline

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

Enrollment ^ICMJE

340

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1

Exclusion Criteria:

Any significant disease or disorder that may jeopardize the safety of the patient
Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Additional inclusion and exclusion criteria will be evaluated by the Investigator

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00252785

Responsible Party

Study ID Numbers ^ICMJE

D5890C00010

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

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