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.

First Received on November 11, 2005. Last Updated on January 21, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252785

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 III

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:

MedlinePlus related topics: Asthma

Drug Information available for: Theophylline Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate Theophylline sodium glycinate

U.S. FDA Resources

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:

Other Name: Symbicort

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

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
Theophylline
Budesonide
Formoterol
Symbicort
Purinergic P1 Receptor Antagonists
Purinergic Antagonists

Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012