- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146392
An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease (PATHOS)
June 17, 2014 updated by: AstraZeneca
A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
27394
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- COPD diagnosis according to medical records.
- Use of drugs prescribed for obstructive lung diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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1
Primary care patients with COPD diagnosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Describe the development of COPD health care structure in primary care.
Time Frame: Data will be extracted from the medical records on one occassion, covering a period of one decade.
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Data will be extracted from the medical records on one occassion, covering a period of one decade.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Describe the COPD population in primary care with special reference to treatment, co-morbidity and mortality during last decade.
Time Frame: Data will be extracted from the medical records on one occassion, covering a period of one decade.
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Data will be extracted from the medical records on one occassion, covering a period of one decade.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Docent Gunnar Johansson, Uppsala University, Sweden
- Study Chair: Kjell Larsson, Prof, Karolinska Institutet
- Study Director: Georgios Stratelis, MD, AstraZeneca Nordics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: BMJ. 2013;346:f4375.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
June 17, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RSE-DUM-2010/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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