Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for Chronic Obstructive Pulmonary Disease (COPD) Patients
This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01713075
First received: October 19, 2012
Last updated: April 24, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the post-marketing actual use.
| Condition |
|---|
|
Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for COPD Patients |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Adverse event incidence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical questionnaire about chronic obstructive pulmonary disease(CCQ) [ Time Frame: At baseline, Week 12, Week 26, 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Symbicort |
Detailed Description:
Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for long-term use for COPD patients
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time
Criteria
Inclusion Criteria:
- Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713075
Contacts
| Contact: AstraZeneca Clinical Study Information | Miyo.Ishihara@astrazeneca.com |
Locations
| Japan | |
| Research Site | Recruiting |
| Aichi, Japan | |
| Research Site | Recruiting |
| Akita, Japan | |
| Research Site | Recruiting |
| Aomori, Japan | |
| Research Site | Recruiting |
| Chiba, Japan | |
| Research Site | Recruiting |
| Ehime, Japan | |
| Research Site | Recruiting |
| Fukui, Japan | |
| Research Site | Recruiting |
| Fukuoka, Japan | |
| Research Site | Recruiting |
| Fukushima, Japan | |
| Research Site | Recruiting |
| Gifu, Japan | |
| Research Site | Recruiting |
| Gunma, Japan | |
| Research Site | Recruiting |
| Hiroshima, Japan | |
| Research Site | Recruiting |
| Hokkaido, Japan | |
| Research Site | Recruiting |
| Hyogo, Japan | |
| Research Site | Recruiting |
| Ibaraki, Japan | |
| Research Site | Recruiting |
| Ishikawa, Japan | |
| Research Site | Recruiting |
| Iwate, Japan | |
| Research Site | Recruiting |
| Kagawa, Japan | |
| Research Site | Recruiting |
| Kagoshima, Japan | |
| Research Site | Recruiting |
| Kanagawa, Japan | |
| Research Site | Recruiting |
| Kochi, Japan | |
| Research Site | Recruiting |
| Kumamoto, Japan | |
| Research Site | Recruiting |
| Kyoto, Japan | |
| Research Site | Recruiting |
| Mie, Japan | |
| Research Site | Recruiting |
| Miyagi, Japan | |
| Research Site | Recruiting |
| Miyazaki, Japan | |
| Research Site | Recruiting |
| Nagano, Japan | |
| Research Site | Recruiting |
| Nagasaki, Japan | |
| Research Site | Recruiting |
| Nara, Japan | |
| Research Site | Recruiting |
| Niigata, Japan | |
| Research Site | Recruiting |
| Oita, Japan | |
| Research Site | Recruiting |
| Okayama, Japan | |
| Research Site | Recruiting |
| Okinawa, Japan | |
| Research Site | Recruiting |
| Osaka, Japan | |
| Research Site | Recruiting |
| Saga, Japan | |
| Research Site | Recruiting |
| Saitama, Japan | |
| Research Site | Recruiting |
| Shiga, Japan | |
| Research Site | Recruiting |
| Shimane, Japan | |
| Research Site | Recruiting |
| Shizuoka, Japan | |
| Research Site | Recruiting |
| Tochigi, Japan | |
| Research Site | Recruiting |
| Tokushima, Japan | |
| Research Site | Recruiting |
| Tokyo, Japan | |
| Research Site | Recruiting |
| Tottori, Japan | |
| Research Site | Recruiting |
| Toyama, Japan | |
| Research Site | Recruiting |
| Wakayama, Japan | |
| Research Site | Recruiting |
| Yamagata, Japan | |
| Research Site | Recruiting |
| Yamanashi, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Shigeru Yoshida, MD | Astrazeneca KK |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01713075 History of Changes |
| Other Study ID Numbers: | D589DL00001 |
| Study First Received: | October 19, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
chronic obstructive pulmonary disease Symbicort long-term use |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract 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 16, 2013