Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255255

Purpose

This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/Formoterol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate

Secondary Outcome Measures:

Patient reported outcomes regarding disease status (incl. PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
- all variables assessed over the 52 week treatment period

Estimated Enrollment:	120
Study Start Date:	November 2005
Study Completion Date:	June 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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
Prescribed daily use of at least one of the following:

Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255255

Locations

Japan
Research Site
Komaki, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Ora, Gunma, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Tomakomai, Hokkaido, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
Beppu, Ohita, Japan
Research Site
Tsukubo-gun, Okayama, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Takatsuki, Osaka, Japan
Research Site
Ota-ku, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Gifu, Japan
Research Site
Hiroshima, Japan
Research Site
Kagoshima, Japan
Research Site
Kochi, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00255255 History of Changes
Other Study ID Numbers:	D5890C00009
Study First Received:	November 17, 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
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012