AsthmaNCT01369810
Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Sweden.
Trial summary
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- How many people
- 20,000 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2011to Sep 2013
- 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: All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Who may be able to join
- All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- Epidemiological, asthma, COPD, reimbursement, switch, outcomes associated with the change in reimbursement
- Medical subject headings
- Asthma, 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 |
|---|---|---|
| 1 | All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure
Measured: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
Secondary outcomes (2)
To map out the development of asthma and COPD treatment in Iceland after the change in reimbursement
Measured: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
To investigate health economic outcomes
Measured: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Unnur Steina Björnsdottir, MD, Principal investigator, University of IcelandSveinbjörn Gizurason, Principal investigator, University of IcelandGeorgios Stratelis, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369810
- Sponsor's protocol ID
- NIS-RSE-DUM-2010/2
- Status last verified
- Nov 2013
- First submitted
- 8 Jun 2011
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland
- ClinicalTrials.gov ID
- NCT01369810
- Acronym / sponsor ID
- NIS-RSE-DUM-2010/2
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- Epidemiological, asthma, COPD, reimbursement, switch, outcomes associated with the change in reimbursement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Jun 2011 (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.
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Key inclusion criteria (1 listed)
- All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
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
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure
Time frame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
2 secondary outcomes
To map out the development of asthma and COPD treatment in Iceland after the change in reimbursement
Time frame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
To investigate health economic outcomes
Time frame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years
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 2 Dec 2013.
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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.
Unnur Steina Björnsdottir, MD principal investigator
University of Iceland
Sveinbjörn Gizurason principal investigator
University of Iceland
Georgios Stratelis, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Sweden.
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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure (time frame: Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years). 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 2 Dec 2013.