Chronic Obstructive Pulmonary DiseasePATHOSNCT01146392
An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 27,394 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- COPD diagnosis according to medical records.
- Use of drugs prescribed for obstructive lung diseases
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Epidemiological, COPD health care, treatment in primary care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Primary care patients with COPD diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the development of COPD health care structure in primary care.
Measured: 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.
Measured: Data will be extracted from the medical records on one occassion, covering a period of one decade.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 27,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Docent Gunnar Johansson, Principal investigator, Uppsala University, SwedenKjell Larsson, Prof, Study chair, Karolinska InstitutetGeorgios Stratelis, MD, Study director, AstraZeneca Nordics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146392
- Sponsor's protocol ID
- NIS-RSE-DUM-2010/1
- Acronym
- PATHOS
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23495860Stallberg 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.
PubMed 24346825Sandelin 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.
PubMed 29922050Lisspers 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.
PubMed 25002194Janson 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.
PubMed 23719639
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01146392
- Acronym / sponsor ID
- PATHOS / NIS-RSE-DUM-2010/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Epidemiological, COPD health care, treatment in primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,394 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Primary care patients with COPD diagnosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COPD diagnosis according to medical records.
- Use of drugs prescribed for obstructive lung diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Results publication: PubMed 23495860Larsson 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.
- Results publication: PubMed 24346825Stallberg 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.
- Derived from this study: PubMed 29922050Sandelin 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.
- Derived from this study: PubMed 25002194Lisspers 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.
- Derived from this study: PubMed 23719639Janson 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 InfoLink provided by the sponsor.
- CSR-NIS-RSE-DUM-2010-1.pdfLink provided by the sponsor.
- NIS-RSE-DUM-2010/1 Clinical Report SynopsisLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Docent Gunnar Johansson principal investigator
Uppsala University, Sweden
Kjell Larsson, Prof study chair
Karolinska Institutet
Georgios Stratelis, MD study director
AstraZeneca Nordics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146392, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.