Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation (ENSURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01232335
First received: October 31, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage


Condition
Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation for Long-term Use

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Range of one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The level of asthma control under long-term use [ Time Frame: At the end of 24 weeks ] [ Designated as safety issue: No ]
  • The level of asthma control under long-term use [ Time Frame: At the end of one year ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: January 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with Symbicort for the first time due to bronchial asthma

Criteria

Inclusion Criteria:

  • Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232335

Locations
Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Yoshida Shigeru AstraZeneca K.K.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01232335     History of Changes
Other Study ID Numbers: D589IC00001
Study First Received: October 31, 2010
Last Updated: May 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
bronchial asthma
Symbicort
long term use,

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Budesonide
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014