OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

NCT03386994 | Completed Results

• 1 other identifier: 1199-0296
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 31

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)

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Idiopathic Pulmonary Fibrosis (IPF)-Related Costs

  The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.

  12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).

Secondary Outcomes (18)

• Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)

  12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).

• Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)

  12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).

• Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index

  12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).

• Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year

  12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).

• Total Annual Acute Exacerbation-related Costs

  12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).

Study Arms (1)

Idiopathic Pulmonary Fibrosis patients

all IPF patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (31)

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital Universitario Cruces

Barakaldo (Vizcaya), 48903, Spain

Location

H. del Mar

Barcelona, 8003, Spain

Location

H. U. Vall d'Hebron

Barcelona, 8035, Spain

Location

H. U. de Bellvitge

Barcelona, 8907, Spain

Location

H. U. Germans Trias i Pujol

Barcelona, 8916, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital General Universitario Santa Lucía

Cartagena (Murcia), 30202, Spain

Location

Hospital General Universitario de Castellón

Castellon, 12004, Spain

Location

H. U. de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Can Misses

Ibiza Town, 7800, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

H. Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda (Madrid), 28222, Spain

Location

H. Son Llatzer

Mallorca, 7198, Spain

Location

H. de Manacor

Mallorca, 7500, Spain

Location

Hospital Costa del Sol

Marbella (Málaga), 29603, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

H. Mateu Orfila

Menorca, 7703, Spain

Location

Hospital Montecelo

Mourente (Pontevedra), 36071, Spain

Location

CHU de Ourense

Ourense, 32005, Spain

Location

H. Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07020, Spain

Location

Hospital Universitario Donostia

San Sebastián, 20014, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Sierrallana y Tres Mares

Torrelavega (Cantabria), 39300, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Mireia Canals, +34607550925

  mireia.canals@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 29, 2017
• Study Start: November 29, 2017
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: November 9, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-10

Locations

ES (31)