NCT01146392

Brief Summary

The aim of this study is to describe COPD health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (COPD) population in real life in primary care during the last ten years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27,394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

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

Study Start

First participant enrolled

June 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 16, 2010

Last Update Submit

June 17, 2014

Conditions

Keywords

EpidemiologicalCOPD health caretreatment in primary care

Outcome Measures

Primary Outcomes (1)

  • Describe the development of COPD health care structure in primary care.

    Data will be extracted from the medical records on one occassion, covering a period of one decade.

Secondary Outcomes (1)

  • Describe the COPD population in primary care with special reference to treatment, co-morbidity and mortality during last decade.

    Data will be extracted from the medical records on one occassion, covering a period of one decade.

Study Arms (1)

1

Primary care patients with COPD diagnosis

Eligibility Criteria

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

Eligible subjects are all COPD patients, found in medical records at the participating swedish primary care clinics. Primarily patients with diagnosis code J44 (ICD-10) stated in the medical record will be investigated. Patient data from the period 1 January 1999 - 31 December 2009 will be included in the observation.

You may qualify if:

  • COPD diagnosis according to medical records.
  • Use of drugs prescribed for obstructive lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

Related Publications (5)

  • Larsson K, Janson C, Lisspers K, Jorgensen L, Stratelis G, Telg G, Stallberg B, Johansson G. Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. J Intern Med. 2013 Jun;273(6):584-94. doi: 10.1111/joim.12067. Epub 2013 Apr 1.

  • Stallberg B, Janson C, Johansson G, Larsson K, Stratelis G, Telg G, Lisspers KH. Management, morbidity and mortality of COPD during an 11-year period: an observational retrospective epidemiological register study in Sweden (PATHOS). Prim Care Respir J. 2014 Mar;23(1):38-45. doi: 10.4104/pcrj.2013.00106.

  • Sandelin M, Mindus S, Thuresson M, Lisspers K, Stallberg B, Johansson G, Larsson K, Janson C. Factors associated with lung cancer in COPD patients. Int J Chron Obstruct Pulmon Dis. 2018 Jun 6;13:1833-1839. doi: 10.2147/COPD.S162484. eCollection 2018.

  • Lisspers K, Johansson G, Jansson C, Larsson K, Stratelis G, Hedegaard M, Stallberg B. Improvement in COPD management by access to asthma/COPD clinics in primary care: data from the observational PATHOS study. Respir Med. 2014 Sep;108(9):1345-54. doi: 10.1016/j.rmed.2014.06.002. Epub 2014 Jun 17.

  • Janson C, Larsson K, Lisspers KH, Stallberg B, Stratelis G, Goike H, Jorgensen L, Johansson G. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting beta2 agonist: observational matched cohort study (PATHOS). BMJ. 2013 May 29;346:f3306. doi: 10.1136/bmj.f3306.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Docent Gunnar Johansson

    Uppsala University, Sweden

    PRINCIPAL INVESTIGATOR
  • Kjell Larsson, Prof

    Karolinska Institutet

    STUDY CHAIR
  • Georgios Stratelis, MD

    AstraZeneca Nordics

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations