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Real world effects of medications for chronic obstructive pulmonary disease

The effects of medications for chronic obstructive pulmonary disease on mortality, pneumonia and exacerbation rate amongst UK patients with COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN73872958
Enrollment
6000
Registered
2016-12-05
Start date
2017-05-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

Electronic patient medical records will be searched for prescriptions of study medication, as issued under routine clinical care. Based on these records patients will then be assigned to appropriate t

Sponsors

National Institute for Health Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For the primary analysis, the following inclusion criteria will apply: 1. A diagnosis of COPD, 2. Age 40-80 years, 3. Lung function (FEV180 years, OR 2. History of lung surgery OR 3. History of long term oxygen therapy OR 4. Evidence of drug/alcohol abuse OR 5. Substantial comorbidity For the analysis of people with mild COPD, the following criteria will apply: 1. COPD diagnosis 2. >60% predicted FEV1 (or >50% plus MRC score 1 or 2, or >50% plus CAT score <10) 3. A maximum of 1 exacerbation in the year post COPD diagnosis

Exclusion criteria

Exclusion criteria: For the primary analysis closely mirroring the TORCH study, exclusions are: 1. History of asthma 2. History of lung surgery 3. Requirement for long-term oxygen therapy 4. Diagnosed alpha-1 antitrypsin deficiency 5. Evidence of drug/alcohol abuse For the secondary anlayses: There are no exclusion criteria.

Design outcomes

Primary

MeasureTime frame
1. COPD exacerbation rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment 2. Mortality rate will be determined using primary care electronic health records and linked hospital records and linked office for national statistics mortality records, within three years of starting treatment 3. Pneumonia rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment

Secondary

MeasureTime frame
Time to change in treatment for COPD will be determined using primary care electronic health records within three years of starting treatment

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026