Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation (ENSURE)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01232335
First received: October 31, 2010
Last updated: February 4, 2013
Last verified: February 2013
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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 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 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 | |
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| Aichi, Japan | |
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| Akita, Japan | |
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| Aomori, Japan | |
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| Chiba, Japan | |
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| Ehime, Japan | |
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| Fukui, Japan | |
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| Fukuoka, Japan | |
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| Fukushima, Japan | |
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| Gifu, Japan | |
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| Gunma, Japan | |
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| Hiroshima, Japan | |
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| Hokkaido, Japan | |
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| Hyogo, Japan | |
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| Ibaraki, Japan | |
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| Ishikawa, Japan | |
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| Iwate, Japan | |
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| Kagawa, Japan | |
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| Kagoshima, Japan | |
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| Kanagawa, Japan | |
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| Kochi, Japan | |
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| Kumamoto, Japan | |
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| Kyoto, Japan | |
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| Mie, Japan | |
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| Miyagi, Japan | |
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| Miyazaki, Japan | |
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| Nagano, Japan | |
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| Nagasaki, Japan | |
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| Nara, Japan | |
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| Niigata, Japan | |
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| Oita, Japan | |
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| Okayama, Japan | |
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| Okinawa, Japan | |
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| Osaka, Japan | |
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| Saga, Japan | |
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| Saitama, Japan | |
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| Shiga, Japan | |
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| Shimane, Japan | |
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| Shizuoka, Japan | |
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| Tochigi, Japan | |
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| Tokushima, Japan | |
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| Tokyo, Japan | |
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| Tottori, Japan | |
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| Toyama, Japan | |
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| Wakayama, Japan | |
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| Yamagata, Japan | |
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| Yamaguchi, Japan | |
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| 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: | February 4, 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 May 21, 2013