Chronic Obstructive Pulmonary DiseaseNCT01749462
Oxis 9mcg Turbuhaler Clinical Experience Investigation
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 41 sites in Japan.
Trial summary
The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 398 participants
- Where
- 41 sitesJapan
- Study dates
- Feb 2013to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Who may be able to join
- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Who cannot join
None listed.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Japan41 sites
Research Site
Aichi, D5127l00001
Research Site
Akita, D5127l00001
Research Site
Aomori, D5127l00001
Research Site
Chiba, D5127l00001
Research Site
Fukuoka, D5127l00001
Research Site
Fukushima, D5127l00001
Research Site
Gifu, D5127l00001
Research Site
Gunma, D5127l00001
Research Site
Hiroshima, D5127l00001
Research Site
Hokkaido, D5127l00001
Research Site
Hyōgo, D5127l00001
Research Site
Ibaraki, D5127l00001
Research Site
Ishikawa, D5127l00001
Research Site
Kagawa, D5127l00001
Research Site
Kagoshima, D5127l00001
Research Site
Kanagawa, D5127l00001
Research Site
Kochi, D5127l00001
Research Site
Kyoto, D5127l00001
Research Site
Mie, D5127l00001
Research Site
Miyagi, D5127l00001
Research Site
Miyazaki, D5127l00001
Research Site
Nagano, D5127l00001
Research Site
Nagasaki, D5127l00001
Research Site
Nara, D5127l00001
Research Site
Niigata, D5127l00001
Research Site
Numakunai, D5127l00001
Research Site
Ōita, D5127l00001
Research Site
Okayama, D5127l00001
Research Site
Okinawa, D5127l00001
Research Site
Osaka, D5127l00001
Research Site
Saitama, D5127l00001
Research Site
Shiga, D5127l00001
Research Site
Shimane, D5127l00001
Research Site
Shizuoka, D5127l00001
Research Site
Tochigi, D5127l00001
Research Site
Tokushima, D5127l00001
Research Site
Tokyo, D5127l00001
Research Site
Toyama, D5127l00001
Research Site
Yamagata, D5127l00001
Research Site
Yamaguchi, D5127l00001
Research Site
Yamanashi, D5127l00001
About this study
The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.
Read the detailed description
Oxis 9mcg Turbuhaler Clinical Experience Investigation
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease,, COPD,, Oxis,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oxis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Yoshida, MD, Study director, Astrazeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749462
- Sponsor's protocol ID
- D5127L00001
- Status last verified
- Feb 2016
- First submitted
- 12 Dec 2012
- Last updated
- 10 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxis 9mcg Turbuhaler Clinical Experience Investigation
- ClinicalTrials.gov ID
- NCT01749462
- Acronym / sponsor ID
- D5127L00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease,, COPD,, Oxis,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.
Detailed description
Oxis 9mcg Turbuhaler Clinical Experience Investigation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxis | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Key inclusion criteria (1 listed)
- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse event incidence
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Yoshida, MD study director
Astrazeneca KK
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 41 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event incidence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.