Observational Analysis on the Socio-economic Impact of Idiopathic Pulmonary Fibrosis (IPF) in Spain (OASIS-IPF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39833
• EU PAS number:
  EUPAS19387
• Study ID:
  39833
• Official title and acronym:
  Observational Analysis on the Socio-economic Impact of Idiopathic Pulmonary Fibrosis (IPF) in Spain (OASIS-IPF)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  IPF is a chronic, progressive fibrosing interstitial pneumonia of unknow cause. There is no evidence on the costs of patients with IPF in Spain based on actual clinical practice. The main objective is to compare the economic impact of IPF according to FVC % predicted level (FVC<50%, FVC 50-80%, FVC>80%), in adult patients through estimation of annual direct and indirect costs associated with the disease at in one year. Secondary Objectives: - To estimate the QoL of the patients with IPF according to FVC % predicted level, through SGRQ and EQ-5D-5L questionnaires and the Barthel Index at baseline. - To explore the determinants of costs and QoL in patients with IPF according to FVC % predicted level. - To characterize acute IPF exacerbations along one year (frequency and cost) according to FVC % predicted level at baseline. - To describe the variation of costs and QoL with IPF progression (according to the FVC deterioration). - To explore the impact of disease on the patient’s caregiver through Zarit Burden Interview questionnaire at 6 and 12 month. Non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services). IPF patients will be enrolled in a consecutive manner over a period of 6 month. Based on the investigation into the viability of recruitment, we expect to include 200 patients approximately. Inclusion criteria: - Female and male patients ≥40 years of age. - Patients diagnosed with IPF according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus. - Written informed consent prior to participation. Exclusion criteria: - Inability for the patient to understand or complete the written Informed Consent or patient questionnaires or to understand Spanish. - Current participation in any clinical trial. - Patients for whom further follow-up is not possible at the enrolling site.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 14/10/2016

Actual: 14/10/2016

Study start date

Planned: 30/11/2017

Actual: 18/12/2017

Data analysis start date

Planned: 04/11/2019

Actual: 23/12/2019

Date of final study report

Planned: 16/09/2020

Actual: 17/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Spain S.A.

Regulatory

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