Chronic Obstructive Pulmonary DiseaseCoCONCT01263340
Characterisation of People With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by National Services for Health Improvement Ltd at 1 site in United Kingdom.
Trial summary
The investigators will describe the characteristics, prevalence, incidence, severity co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in the UK. 100 practices will be sampled amounting to a total study population of about 10 000 patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 10,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Apr 2013
- 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: People with a Read code diagnosis of COPD
Who may be able to join
- people with a read code diagnosis of COPD
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Multi-centre, Retrospective Cohort Study to Evaluate Prevalence, Incidence, Severity, Co-morbidities and Burden of Disease in Patients With a Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) by Close Scrutiny of the Patient Journey
The investigators will describe the characteristics, prevalence, incidence, severity co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in the UK. 100 practices will be sampled amounting to a total study population of about 10 000 patients. Information will be collected electronically and, where necessary, by a hand search of patient records.
Read the detailed description
Research questions:
- What is the recorded prevalence of COPD in the UK? [numerator: the prevalence of COPD defined as ANY current READ code for COPD or inclusion in a COPD register denominator: the whole population]
- What proportion of this population has documented spirometry to confirm the diagnosis?
- What proportion has documented spirometry in the last year?
- What proportion has ever had a documented history of asthma?
- What proportion currently has a documented history of asthma?
- What proportion currently smokes?
- What proportion of smokers has a record of receiving smoking cessation advice?
- What proportion of smokers has had a prescription for smoking cessation therapy?
- What proportion of people with COPD has a READ code for exception reporting?
- What are their demographic features? (height weight, BMI, age, smoking status, forced expiratory flow in 1st second (FEV1_, DOSE)
- What proportion of people with COPD has a READ code for exception reporting from spirometry?
- What are their demographic features? (height, weight, body mass index (BMI), age, smoking status, FEV1, DOSE) Sub analysis: descriptions and comparison of prevalence by • Age
- geographical location of participating practices
- primary care training practice
- number of performing general practitioners (GPs) in practice (<3 v >/= 3)
- What is the incidence of COPD in the UK
- number of people with a new diagnosis of COPD in the last year as a proportion of the whole population
- What is the distribution of severities of COPD?
- Description of severity of airflow obstruction by FEV1 measurement: Mild (FEV1 ≥ 80% predicted): Moderate (FEV1 50% to 79% predicted) Severe (FEV1 30% to 49% predicted) Very severe (FEV1 ≤ 30% predicted)
- And by DOSE Compare the severity of disease (exacerbation rate) according to DOSE "high risk" and "low risk" and compare this to the stratification of severity in the study population by degree of airflow limitation.
- And by COPD Assessment Test (CAT) Explore the use of CAT in clinical practice and the availability and spread of data
- What is the exacerbation rate?
- In the last year in people with a diagnosis of COPD > 1 year
- In the last three years in people with a diagnosis of COPD > 3years (as a proportion of the population with COPD).
- What is the seasonal variation of COPD exacerbations: what proportion of exacerbations occurs in each month of the year?
- Do recurrent primary care managed exacerbations predict hospital admissions? What is the prior exacerbation rate in patients admitted to hospital? Population of interest: those with hospital admissions for COPD: what is the exacerbation rate (and time frame of exacerbations) prior to a hospital admission? 4a. What proportion of the COPD population had at least one exacerbation? Hospital attendance: Any documented visit to any secondary care (not primary care out of hours) site with no overnight stay Hospital admission: Any documented visit to any secondary care site with an overnight stay with a principal diagnosis of COPD or chest infection or pneumonia or exacerbation of asthma ICU admission: Any documented admission to any high dependency unit (note, AN EXPLORATORY EXERCISE. Validity of this data in primary care record is questionable) Death: Any death with COPD documented as the primary cause or within 14 days of the onset of an exacerbation (EXPLORATORY)
- Does DOSE predict undesirable outcomes (death, hospital admission, exacerbation rate)?
- Does FEV1 predict undesirable outcomes (death, hospital admission, exacerbation rate)?
- Does medical research council dyspnoea (MRC) score (or other component of DOSE) predict undesirable outcomes?
- Possible exploratory analysis: does ADO index (Age, Dyspnoea (MRC score) Obstruction (FEV1 % pred)) predict undesirable outcomes?
- Does number of patients in a practice receiving a Tiotropium prescription predict hospital admission at a practice level?
- Therapy:
- What proportion of patients (without a diagnosis of asthma) receives inhaled glucocorticosteroids at unlicensed doses (any steroid (fluticasone, budesonide, beclometasone, ciclesonide) or combination Seretide, Symbicort, Fostair) EXCEPT Seretide Accuhaler 50/500 or Symbicort?
- What proportion of patients with FEV1> 50 and no diagnosis of asthma receive any steroid preparation? (Note: Seretide Accuhaler 50/500 is licensed for use in patients with COPD and (pre-bronchodilator) FEV1 < 60% predicted and is therefore not subject to off label use in this instance). The approach outlined here is a consensus for the purposes of identifying a pragmatic approach to data collection.
- What proportion of patients with FEV<50 do not receive any inhaled steroid?
- What proportion of patients with 1 or more exacerbation in the last year does not receive any inhaled steroid?
- What proportion of patients with FEV1 <50 do not receive Seretide 50/500 or Symbicort?
- What proportion of patients are on "triple therapy" i.e. Seretide or Symbicort PLUS Tiotropium, classified by severity (FEV1)
- What is the refill rate for prescriptions by class (all above and SABA) in the previous year?
- What proportion of patients have an MRC dyspnoea score >/= 3?
- What proportion of these patients has been referred for pulmonary rehabilitation?
- What proportion has received pulmonary rehabilitation?
- What proportion has documented evidence of receiving a self management plan?
- Co-morbidities: What proportion of patients with COPD have any READ code ever for the following co-morbidities:
- Cardiovascular disease
- Cerebrovascular disease
- Diabetes Mellitus
- Cancer
- Lung cancer
- Depression
- Osteoporosis What proportion of patients with at least one comorbidity has attended a specialist chest service / clinic in the last year? What is the exacerbation rate in this group v patients without comorbidity? What is the hospital admission rate in this group v the rest? What proportion of the population has a record of NEVER smoking? What are the features of this group (age, sex, geography, exacerbation rate, medication, comorbidities
- Newly diagnosed patients
- What are the characteristics (demographics: height weight, BMI, age, smoking status, FEV1, DOSE) of newly diagnosed patients (first READ code for COPD within the last year)?
- What proportion of these patients received a prescription for Tiotropium within 1 month of diagnosis?
- What proportion of these patients received a prescription for an inhaled corticosteroid / longa acting beta-agonist fixed dose (ICS / LABA) combination within 1 month of diagnosis?
- In patients FEV1 <50% predicted, what proportion receive a) Tiotropium and b) an ICS / LABA combination first
- What proportion of these patients with FEV1>50 received a prescription for ICS / LABA combination within 1 month of diagnosis?
- General Practice Research database (GPRD)
- What proportion of our sample currently contributes to the GPRD database?
- Are their differences in the features of the two groups: Age geographical location of participating practices, primary care training practice, number of performing GPs in practice (<3 v >/= 3), disease severity (DOSE, FEV1) exacerbation rate
- What changes have there been at practice level to the above parameters in the last year?
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, observational study, prevalence, characterisation
- 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 |
|---|---|---|
| People with COPD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and characterisation of people with COPD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Services for Health Improvement Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- John Haughney, FRCPE FRCGP, Principal investigator, NSHI Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263340
- Sponsor's protocol ID
- SCO115217
- Acronym
- CoCO
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2010
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haughney J, Gruffydd-Jones K, Roberts J, Lee AJ, Hardwell A, McGarvey L. The distribution of COPD in UK general practice using the new GOLD classification. Eur Respir J. 2014 Apr;43(4):993-1002. doi: 10.1183/09031936.00065013. Epub 2013 Oct 31.
PubMed 24176990
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Multi-centre, Retrospective Cohort Study to Evaluate Prevalence, Incidence, Severity, Co-morbidities and Burden of Disease in Patients With a Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) by Close Scrutiny of the Patient Journey
- ClinicalTrials.gov ID
- NCT01263340
- Acronym / sponsor ID
- CoCO / SCO115217
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, observational study, prevalence, characterisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Services for Health Improvement LtdIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Dec 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 investigators will describe the characteristics, prevalence, incidence, severity co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in the UK. 100 practices will be sampled amounting to a total study population of about 10 000 patients. Information will be collected electronically and, where necessary, by a hand search of patient records.
Detailed description
Research questions:
- What is the recorded prevalence of COPD in the UK? [numerator: the prevalence of COPD defined as ANY current READ code for COPD or inclusion in a COPD register denominator: the whole population]
- What proportion of this population has documented spirometry to confirm the diagnosis?
- What proportion has documented spirometry in the last year?
- What proportion has ever had a documented history of asthma?
- What proportion currently has a documented history of asthma?
- What proportion currently smokes?
- What proportion of smokers has a record of receiving smoking cessation advice?
- What proportion of smokers has had a prescription for smoking cessation therapy?
- What proportion of people with COPD has a READ code for exception reporting?
- What are their demographic features? (height weight, BMI, age, smoking status, forced expiratory flow in 1st second (FEV1_, DOSE)
- What proportion of people with COPD has a READ code for exception reporting from spirometry?
- What are their demographic features? (height, weight, body mass index (BMI), age, smoking status, FEV1, DOSE) Sub analysis: descriptions and comparison of prevalence by • Age
- geographical location of participating practices
- primary care training practice
- number of performing general practitioners (GPs) in practice (<3 v >/= 3)
- What is the incidence of COPD in the UK
- number of people with a new diagnosis of COPD in the last year as a proportion of the whole population
- What is the distribution of severities of COPD?
- Description of severity of airflow obstruction by FEV1 measurement: Mild (FEV1 ≥ 80% predicted): Moderate (FEV1 50% to 79% predicted) Severe (FEV1 30% to 49% predicted) Very severe (FEV1 ≤ 30% predicted)
- And by DOSE Compare the severity of disease (exacerbation rate) according to DOSE "high risk" and "low risk" and compare this to the stratification of severity in the study population by degree of airflow limitation.
- And by COPD Assessment Test (CAT) Explore the use of CAT in clinical practice and the availability and spread of data
- What is the exacerbation rate?
- In the last year in people with a diagnosis of COPD > 1 year
- In the last three years in people with a diagnosis of COPD > 3years (as a proportion of the population with COPD).
- What is the seasonal variation of COPD exacerbations: what proportion of exacerbations occurs in each month of the year?
- Do recurrent primary care managed exacerbations predict hospital admissions? What is the prior exacerbation rate in patients admitted to hospital? Population of interest: those with hospital admissions for COPD: what is the exacerbation rate (and time frame of exacerbations) prior to a hospital admission? 4a. What proportion of the COPD population had at least one exacerbation? Hospital attendance: Any documented visit to any secondary care (not primary care out of hours) site with no overnight stay Hospital admission: Any documented visit to any secondary care site with an overnight stay with a principal diagnosis of COPD or chest infection or pneumonia or exacerbation of asthma ICU admission: Any documented admission to any high dependency unit (note, AN EXPLORATORY EXERCISE. Validity of this data in primary care record is questionable) Death: Any death with COPD documented as the primary cause or within 14 days of the onset of an exacerbation (EXPLORATORY)
- Does DOSE predict undesirable outcomes (death, hospital admission, exacerbation rate)?
- Does FEV1 predict undesirable outcomes (death, hospital admission, exacerbation rate)?
- Does medical research council dyspnoea (MRC) score (or other component of DOSE) predict undesirable outcomes?
- Possible exploratory analysis: does ADO index (Age, Dyspnoea (MRC score) Obstruction (FEV1 % pred)) predict undesirable outcomes?
- Does number of patients in a practice receiving a Tiotropium prescription predict hospital admission at a practice level?
- Therapy:
- What proportion of patients (without a diagnosis of asthma) receives inhaled glucocorticosteroids at unlicensed doses (any steroid (fluticasone, budesonide, beclometasone, ciclesonide) or combination Seretide, Symbicort, Fostair) EXCEPT Seretide Accuhaler 50/500 or Symbicort?
- What proportion of patients with FEV1> 50 and no diagnosis of asthma receive any steroid preparation? (Note: Seretide Accuhaler 50/500 is licensed for use in patients with COPD and (pre-bronchodilator) FEV1 < 60% predicted and is therefore not subject to off label use in this instance). The approach outlined here is a consensus for the purposes of identifying a pragmatic approach to data collection.
- What proportion of patients with FEV<50 do not receive any inhaled steroid?
- What proportion of patients with 1 or more exacerbation in the last year does not receive any inhaled steroid?
- What proportion of patients with FEV1 <50 do not receive Seretide 50/500 or Symbicort?
- What proportion of patients are on "triple therapy" i.e. Seretide or Symbicort PLUS Tiotropium, classified by severity (FEV1)
- What is the refill rate for prescriptions by class (all above and SABA) in the previous year?
- What proportion of patients have an MRC dyspnoea score >/= 3?
- What proportion of these patients has been referred for pulmonary rehabilitation?
- What proportion has received pulmonary rehabilitation?
- What proportion has documented evidence of receiving a self management plan?
- Co-morbidities: What proportion of patients with COPD have any READ code ever for the following co-morbidities:
- Cardiovascular disease
- Cerebrovascular disease
- Diabetes Mellitus
- Cancer
- Lung cancer
- Depression
- Osteoporosis What proportion of patients with at least one comorbidity has attended a specialist chest service / clinic in the last year? What is the exacerbation rate in this group v patients without comorbidity? What is the hospital admission rate in this group v the rest? What proportion of the population has a record of NEVER smoking? What are the features of this group (age, sex, geography, exacerbation rate, medication, comorbidities
- Newly diagnosed patients
- What are the characteristics (demographics: height weight, BMI, age, smoking status, FEV1, DOSE) of newly diagnosed patients (first READ code for COPD within the last year)?
- What proportion of these patients received a prescription for Tiotropium within 1 month of diagnosis?
- What proportion of these patients received a prescription for an inhaled corticosteroid / longa acting beta-agonist fixed dose (ICS / LABA) combination within 1 month of diagnosis?
- In patients FEV1 <50% predicted, what proportion receive a) Tiotropium and b) an ICS / LABA combination first
- What proportion of these patients with FEV1>50 received a prescription for ICS / LABA combination within 1 month of diagnosis?
- General Practice Research database (GPRD)
- What proportion of our sample currently contributes to the GPRD database?
- Are their differences in the features of the two groups: Age geographical location of participating practices, primary care training practice, number of performing GPs in practice (<3 v >/= 3), disease severity (DOSE, FEV1) exacerbation rate
- What changes have there been at practice level to the above parameters in the last year?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with COPD | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with a Read code diagnosis of COPD
Key inclusion criteria (1 listed)
- people with a read code diagnosis of COPD
Key exclusion criteria (1 listed)
- none
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
Prevalence and characterisation of people with COPD
Time frame: 1 year
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 5 Dec 2013.
- Derived from this study: PubMed 24176990Haughney J, Gruffydd-Jones K, Roberts J, Lee AJ, Hardwell A, McGarvey L. The distribution of COPD in UK general practice using the new GOLD classification. Eur Respir J. 2014 Apr;43(4):993-1002. doi: 10.1183/09031936.00065013. Epub 2013 Oct 31.
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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.
John Haughney, FRCPE FRCGP principal investigator
NSHI Ltd
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 National Services for Health Improvement Ltd at 1 site in United Kingdom.
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 1 inclusion and 1 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 5 Dec 2013. 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 United Kingdom. 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?
Prevalence and characterisation of people with COPD (time frame: 1 year). 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 NCT01263340, which also lists 1 linked publication.
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 5 Dec 2013.