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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01369810

First received: June 8, 2011

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2011

Last Updated Date

August 31, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01369810 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Asthma
Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

20000

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01369810

Other Study ID Numbers ^ICMJE

NIS-RSE-DUM-2010/2

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Unnur Steina Björnsdottir, MD	University of Iceland
Principal Investigator:	Sveinbjörn Gizurason	University of Iceland
Study Director:	Georgios Stratelis, MD	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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