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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252785
First received: November 11, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide/Formoterol
Drug: Budesonide
Drug: Theophylline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning peak expiratory flow (mPEF)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 340
Study Start Date: October 2005
Study Completion Date: November 2006
Intervention Details:
    Drug: Budesonide/Formoterol
    Other Name: Symbicort
    Drug: Budesonide Drug: Theophylline
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252785

Locations
Japan
Research Site
Komaki, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Noda, Chiba, Japan
Research Site
Touon, Ehime, Japan
Research Site
Mizumaki, Fukuoka, Japan
Research Site
Isesaki, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ora, Gunma, Japan
Research Site
Ota, Gunma, Japan
Research Site
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
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Beppu, Ohita, Japan
Research Site
Tsukubo, Okayama, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Oskasayama, Osaka, Japan
Research Site
Takatsuiki, Osaka, Japan
Research Site
Koshigaya, Saitama, Japan
Research Site
Minamisaitama, Saitama, Japan
Research Site
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
Ube, Yamaguchi, Japan
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252785     History of Changes
Other Study ID Numbers: D5890C00010
Study First Received: November 11, 2005
Last Updated: January 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Asthma

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

ClinicalTrials.gov processed this record on September 18, 2014