NCT01369810

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

June 8, 2011

Last Update Submit

November 29, 2013

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

EpidemiologicalasthmaCOPDreimbursementswitchoutcomes associated with the change in reimbursement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • To investigate health economic outcomes

    Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years

Study Arms (1)

1

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Unnur Steina Björnsdottir, MD

    University of Iceland

    PRINCIPAL INVESTIGATOR

  • Sveinbjörn Gizurason

    University of Iceland

    PRINCIPAL INVESTIGATOR

  • Georgios Stratelis, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

SE(1)