Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
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

Historical cohort database study
Study drug and medical condition

Name of medicine, other

Ipramol Sterinebs, Duoneb

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Short description of the study population

Chronic obstructive pulmonary disease (COPD) patients aged ≥ 35 years who had ≥ 1 prescription for either Ipramol SteriNebs® or DuoNeb® at IPD and at least two years of continuous data (1 year prior and 1 year post 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

2142
Study design details

Main study objective

The aim of this study is to compare Ipramol SteriNebs® with its originator, DuoNeb®. The primary objective is to assess whether effectiveness (in terms ofexacerbations) of Ipramol SteriNebs® is non-inferior to that of DuoNeb®.

Outcomes

The primary outcome of this study is "effectiveness", evaluated in terms of:1. Severe COPD exacerbations (hospitalisations) in outcome period, and2. Moderate and severe COPD exacerbations in outcome period(Please see the attached protocol for full definitions of these outcomes), The secondary outcome of this study is "safety", evaluated in terms of: Adverse Events (AEs). These will include AEs known to be related to Ipramol SteriNebs® and DuoNeb®, as specified in their respective summary of product characteristics. (Please see the attached protocol for detailed definition of this outcome)

Data analysis plan

Statistically significant results will be defined as p<0.05 and trends as 0.05<p<0.10. Summary statistics will be produced for all baseline and outcome variables by therapy. Treatment groups will be compared using t-test / Mann-Whitney U test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.Outcomes analyses: patients may be matched on demographics and key measures of disease severity to minimise confounding, using random selection process through SAS statistical software to avoid selection bias. Effectiveness and safety in the outcome period will be compared between treatment groups using a conditional Poisson regression model. The model will use empirical standard errors (for more conservative confidence interval estimations) and adjustments will be made for potential baseline confounders. The adjusted rate ratio with 95% confidence interval will be reported.