Clinical trial NCT03386994: OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study
Official title: Observational Analysis on the Socio-economic Impact of IPF in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned that data of approximately 200 patients from approximately 25 sites (secondary care sites - Pulmonology services where IPF is diagnosed and managed) in Spain will be collected. All Idiopathic Pulmonary Fibrosis patients who are diagnosed with IPF and attend to a routine visit during the inclusion period and fulfill inclusion/exclusion criteria and provide informed consent to participate will be included in the study.

Brief summary: Descriptive prospective 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)


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 40 years of age
* Patients diagnosed with Idiopathic Pulmonary Fibrosis (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 Inform Consent or patients questionnaires or to understand Spanish
* Current participation in any clinical trial
* Patients for whom further follow-up is not possible at the enrolling site

Primary outcomes:
measure: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
timeFrame: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).
Secondary outcomes:
measure: Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
timeFrame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
measure: Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
timeFrame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
measure: Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
timeFrame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
measure: Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year
timeFrame: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
measure: Total Annual Acute Exacerbation-related Costs
timeFrame: 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).
measure: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
timeFrame: 12 months (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
timeFrame: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).
measure: Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
timeFrame: 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barakaldo (Vizcaya)
country: Spain
facility: Hospital Universitario Cruces
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. U. Vall d'Hebron
city: Barcelona
country: Spain
facility: H. U. de Bellvitge
city: Barcelona
country: Spain
facility: H. U. Germans Trias i Pujol
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cartagena (Murcia)
country: Spain
facility: Hospital General Universitario Santa Lucía
city: Castellón de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
city: Girona
country: Spain
facility: H. U. de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Ibiza
country: Spain
facility: Can Misses
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Majadahonda (Madrid)
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Mallorca
country: Spain
facility: H. Son Llatzer
city: Mallorca
country: Spain
facility: H. de Manacor
city: Marbella (Málaga)
country: Spain
facility: Hospital Costa del Sol
city: Menorca
country: Spain
facility: H. Mateu Orfila
city: Mourente (Pontevedra)
country: Spain
facility: Hospital Montecelo
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Ourense
country: Spain
facility: CHU de Ourense
city: Oviedo
country: Spain
facility: H. Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Torrelavega (Cantabria)
country: Spain
facility: Hospital Sierrallana y Tres Mares
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia Canals, +34607550925
role: STUDY_CHAIR
References: