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

January 21, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Tochigi, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
    • Aichi
      • Komaki, Aichi, Japan
        • Research Site
      • Seto, Aichi, Japan
        • Research Site
    • Chiba
      • Asahi, Chiba, Japan
        • Research Site
      • Noda, Chiba, Japan
        • Research Site
    • Ehime
      • Touon, Ehime, Japan
        • Research Site
    • Fukuoka
      • Mizumaki, Fukuoka, Japan
        • Research Site
    • Gunma
      • Isesaki, Gunma, Japan
        • Research Site
      • Maebashi, Gunma, Japan
        • Research Site
      • Ora, Gunma, Japan
        • Research Site
      • Ota, Gunma, Japan
        • Research Site
    • Hokkaido
      • Chitose, Hokkaido, Japan
        • Research Site
      • Kitahiroshima, Hokkaido, Japan
        • Research Site
      • Obihiro, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Iwate
      • Morioka, Iwate, Japan
        • Research Site
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Ohita
      • Beppu, Ohita, Japan
        • Research Site
    • Okayama
      • Tsukubo, Okayama, Japan
        • Research Site
    • Osaka
      • Kishiwada, Osaka, Japan
        • Research Site
      • Oskasayama, Osaka, Japan
        • Research Site
      • Takatsuiki, Osaka, Japan
        • Research Site
    • Saitama
      • Koshigaya, Saitama, Japan
        • Research Site
      • Minamisaitama, Saitama, Japan
        • Research Site
    • Tokyo
      • Arakawa, Tokyo, Japan
        • Research Site
      • Chiyoda, Tokyo, Japan
        • Research Site
      • Itabashi, Tokyo, Japan
        • Research Site
      • Kodaira, Tokyo, Japan
        • Research Site
      • Nakano-ku, Tokyo, Japan
        • Research Site
      • Ota-ku, Tokyo, Japan
        • Research Site
      • Shinagawa-ku, Tokyo, Japan
        • Research Site
      • Sumida, Tokyo, Japan
        • Research Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Morning peak expiratory flow (mPEF)

Secondary Outcome Measures

Outcome Measure
Forced expiratory volume in one second (FEV1)
Safety:
Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (ESTIMATE)

November 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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