Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational comparative effectiveness study
Study drug and medical condition

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Short description of the study population

Chronic obstructive pulmonary disease patients.
Patients were required to have ≥ 2 fixed dose ICS/LABA and separate LAMA prescriptions, or ≥ 2 fixed dose ICS/LABA/LAMA prescriptions, in the baseline year. The IPD for the cessation group was the first prescription for a single LABA alongside a single LAMA, or a fixed dose LABA/LAMA, without ICS.

The control group patients were required to have ≥ 1 fixed or free combination of ICS/LABA/LAMA in the outcome year. Their index prescription date (IPD) was the date when the patient received a repeated prescription for their baseline triple therapy.
Patients were required to have an IPD prior to 1/12/2018 to allow for a 1-year outcome period; in patients with more than one IPD the first IPD was used for analysis.
Inclusion criteria were: (A) spirometry-confirmed diagnosis of COPD (Read code and FEV1/FVC < 0.7 within 2 years, ever recorded); (B) aged ≥ 40 years at IPD; (C) current or ex-smoker; (D) have ≥ 1 year of continuous patient records in prior to IPD; and (E) ICS medication possession ratio (MPR, (Number of days supplied in period/Days in period) × 100) ≥ 70% in the baseline year.

Exclusion criteria were: (A) asthma Read code during the baseline year; (B) prescribed azithromycin or roflumilast or receiving maintenance treatment with systemic steroids. Patients were excluded from the control group if they had ever had an ICS cessation prior to IPD.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Chronic obstructive pulmonary disease (COPD) patients

Estimated number of subjects

3000
Study design details

Main study objective

Evaluate the effect of ICS cessation in patients with confirmed COPD, managed in a primary care, “real-life” setting. Specifically investigating the effects of ICS withdrawal on - 1) Exacerbation rates 2) Lung function

Outcomes

Time to COPD exacerbation, Exacerbation rate/ Change in FEV1/ Time to addition or change in therapy/ ICS containing treatment adherence/ CAT score/ MRC Dyspnea scale/ Time to last record in database where there is a lack of continuous records (proxy for mortality)/ Time to first consultation with a pneumonia Read code

Data analysis plan

Assuming that the rate of drop out from the database/mortality rate (where recorded) are not significantly different between the ICS cessation and control arm then only those patients with ≥ 1 year of continuous database records post IPD date will be included in the multivariate regression analyses. We will use an intention to treat analysis. Multivariate regression analyses will be used to adjust for confounding variables. Primary outcome - time to event will be analysed using conditional cox proportional hazards regression. Secondary outcomes- will be analysed with conditional logistic, poisson or cox regression, as appropriate.
Documents
Study publications
Magnussen H, Lucas S, Lapperre T, Quint JK, Dandurand RJ, Roche N, Papi A, Pric…