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

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ClinicalTrials.gov Identifier: NCT01369810
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Asthma Chronic Obstructive Pulmonary Disease

Study Design

Study Type : Observational
Actual Enrollment : 20000 participants
Time Perspective: Retrospective
Official Title: Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland
Study Start Date : July 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369810


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Unnur Steina Björnsdottir, MD University of Iceland
Principal Investigator: Sveinbjörn Gizurason University of Iceland
Study Director: Georgios Stratelis, MD AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01369810     History of Changes
Other Study ID Numbers: NIS-RSE-DUM-2010/2
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

Keywords provided by AstraZeneca:
Epidemiological
asthma
COPD
reimbursement
switch
outcomes associated with the change in reimbursement

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases