Historical matched-cohort study assessing whether the use of inhaled corticosteroids shortens time to first diagnosis or accelerates the progression of side effects compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease. (ICS use in COPD patients and risk of side effects)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27572
• EU PAS number:
  EUPAS13218
• Study ID:
  27572
• Official title and acronym:
  Historical matched-cohort study assessing whether the use of inhaled corticosteroids shortens time to first diagnosis or accelerates the progression of side effects compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease. (ICS use in COPD patients and risk of side effects)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The objective is to analyze the relationship between ICS use and Type 2 Diabetes onset, Type 2 Diabetes worsening disease control and disease progression, osteoporosis onset, pneumonia incidence and overuse of ICS. Firstly, these endpoints will be compared between an ICS therapy cohort and non-ICS therapy cohort. Subsequently, they will be analyzed within the ICS-therapy cohort only and compared by ICS average daily dose, ICS cumulative dose, and ICS drug and inhaler device type. This is a historical, matched-cohort study. The study time period is 1990 - present. To account for changes in ICS prescribing in the study period, patients will be matched on index date to ensure they follow a similar time path. For both treatment cohorts a 1-year baseline period prior to the date of first prescription of ICS therapy or first/additional prescription of non-ICS therapy (i.e. the index date) will be followed by a minimum 1-year outcome period. All of the patient’s available data post index date will be utilized.To be included in the ICS cohort, patients may switch between different types of ICS in the outcome period as long as ICS remain part of therapy. Exposure of ICS will be measured from the index date to realization of the outcome (e.g. a Type 2 Diabetes diagnosis) or from index date to the end of the follow up period if the outcome does not occur. A variable will be created, exposure time, to be used as an adjustment in all multivariable analyses. To be included in the non-ICS cohort, patients may be prescribed SABA, LABA, SAMA, LAMA, Methylxanthines and/or compound bronchodilator preparations and may switch between therapies in the outcome period as long as ICS are not prescribed. The number of OCS prescriptions per year of the outcome period and overall prescriptions in the outcome period will be accounted for in the analysis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 01/12/2015

Study start date

Planned: 01/05/2016

Actual: 14/07/2016

Data analysis start date

Planned: 26/06/2016

Date of final study report

Planned: 12/04/2017

Actual: 10/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

ICS use in COPD patients and risk of side effects_ENCEPP registration April 2016

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable