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: November 29, 2013
Last verified: November 2013
  Purpose

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


Condition
Asthma
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20000
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01369810     History of Changes
Other Study ID Numbers: NIS-RSE-DUM-2010/2
Study First Received: June 8, 2011
Last Updated: November 29, 2013
Health Authority: Iceland: National Bioethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014