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NCT01369810 Clinical Trial

Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease

Asthma Clinical Trial

Official title:
Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01369810
Other study ID # NIS-RSE-DUM-2010/2
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated November 29, 2013
Start date July 2011
Est. completion date September 2013

Study information
Verified date November 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Iceland: National Bioethics Committee
Study type Observational

Clinical Trial Summary

To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure

Recruitment information / eligibility
Status Completed
Enrollment 20000
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Research Site Uppsala

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years No
Secondary To map out the development of asthma and COPD treatment in Iceland after the change in reimbursement Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years No
Secondary To investigate health economic outcomes Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years No
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