Real world effects of medications for chronic obstructive pulmonary disease

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory

• Registration Number: ISRCTN73872958
• Lead Sponsor: ational Institute for Health Research

Brief Summary

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29581202/ (added 06/10/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33093119/ (added 06/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-05
• Study Completion: 2020-02-29
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6000

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 (FEV1<60% predicted, FEV1/FVC ratio <70%),
4. Smoking history

For the secondary analyses, the following inclusion criteria apply:
1. Age >80 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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. COPD exacerbation rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment<br> 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<br> 3. Pneumonia rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment<br>

Secondary Outcome Measures

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