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 - Full Text View

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:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:	November 2005
Study Completion Date:	November 2006

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

Hide Study Locations

Locations

Japan
Research Site
Tochigi, 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
Toyama, Japan
Japan, Aichi
Research Site
Komaki, Aichi, Japan
Research Site
Seto, Aichi, Japan
Japan, Chiba
Research Site
Asahi, Chiba, Japan
Research Site
Noda, Chiba, Japan
Japan, Ehime
Research Site
Touon, Ehime, Japan
Japan, Fukuoka
Research Site
Mizumaki, Fukuoka, Japan
Japan, Gunma
Research Site
Isesaki, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ora, Gunma, Japan
Research Site
Ota, Gunma, Japan
Japan, Hokkaido
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
Japan, Iwate
Research Site
Morioka, Iwate, Japan
Japan, Kagawa
Research Site
Takamatsu, Kagawa, Japan
Japan, Miyagi
Research Site
Sendai, Miyagi, Japan
Japan, Ohita
Research Site
Beppu, Ohita, Japan
Japan, Okayama
Research Site
Tsukubo, Okayama, Japan
Japan, Osaka
Research Site
Kishiwada, Osaka, Japan
Research Site
Oskasayama, Osaka, Japan
Research Site
Takatsuiki, Osaka, Japan
Japan, Saitama
Research Site
Koshigaya, Saitama, Japan
Research Site
Minamisaitama, Saitama, Japan
Japan, Tokyo
Research Site
Arakawa, Tokyo, Japan
Research Site
Chiyoda, 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
Itabashi, Tokyo, Japan
Japan, Yamaguchi
Research Site
Ube, Yamaguchi, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5890C00010
Study First Received:	November 11, 2005
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00252785 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Symbicort
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Therapeutic Uses
Formoterol
Adrenergic beta-Agonists
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Glucocorticoids
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on November 27, 2009