OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Observational Analysis on the Socio-economic Impact of IPF in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386994
• Other study ID #: 1199-0296
• Status: Completed
• Start date: November 29, 2017
• Est. completion date: September 16, 2019

Study information

• Verified date: October 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitario Cruces	Barakaldo (Vizcaya)
Spain	H. del Mar	Barcelona
Spain	H. U. de Bellvitge	Barcelona
Spain	H. U. Germans Trias i Pujol	Barcelona
Spain	H. U. Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital General Universitario Santa Lucía	Cartagena (Murcia)
Spain	Hospital General Universitario de Castellón	Castellón de la Plana
Spain	H. U. de Girona Doctor Josep Trueta	Girona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Can Misses	Ibiza
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	H. Clínico San Carlos	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda (Madrid)
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	H. de Manacor	Mallorca
Spain	H. Son Llatzer	Mallorca
Spain	Hospital Costa del Sol	Marbella (Málaga)
Spain	H. Mateu Orfila	Menorca
Spain	Hospital Montecelo	Mourente (Pontevedra)
Spain	CHU de Ourense	Ourense
Spain	H. Central de Asturias	Oviedo
Spain	Hospital Universitari Son Espases	Palma de Mallorca
Spain	Hospital Universitario Donostia	San Sebastián
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital Sierrallana y Tres Mares	Torrelavega (Cantabria)
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)	The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value, is assessed through SGRQ. The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). The number of participants analysed displays the number of participants with available data at the timepoint of interests.	12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Secondary	Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)	The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the EQ-VAS, which is a self-rated health status using a visual analogue scale (VAS), ranging form 0-100, with 0 = worst state of health imaginable and 100 = best state of health imaginable. The EQ-VAS is part of the EuroQoL five dimensions questionaire 5L (EQ-5D-5L).; The number of participants analysed displays the number of participants with available data at the timepoint of interests.	12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Secondary	Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index	The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index.; Barthel Index were used to score the ability of a participant to care for himself. It consists of 10 items, the values assigned to each item are based on time and amount of actual physical assistance required if a participant is unable to perform the activity. The final score ranges from 0 and 100. Participant scoring 100 is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs.; The number of participants analysed displays the number of participants with available data at the timepoint of interests.	12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Secondary	Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year	Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year.; Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.	12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).
Secondary	Total Annual Acute Exacerbation-related Costs	The total annual acute exacerbation-related costs were obtained as the sum of direct and indirect costs for each patient over the follow-up period of 12 months.; For estimation of costs the following variables were used: Acute exacerbation related resource use for direct cost estimation: primary and secondary care visits, emergency visits (primary care and hospital), hospitalizations, ICU with and without intubation (qualitative analysis), outpatient tests and other examinations, use of transport, use of formal caregiver, pharmacological and non-pharmacological treatments (except treatments administered in hospitalization), orthopedic material, formal social services, economic aid and structural adaptations. Acute exacerbation related resource use for indirect cost estimation: patients' days off work and informal caregiver.	12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).
Secondary	Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group	Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.; FVC decline is calculated: FVC% (T12)- FVC%(T0)).; In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0	Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.; FVC decline is calculated: FVC% (T12)- FVC%(T0)).; In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%; Results are reported for participants with predicted FVC <50% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0	Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.; FVC decline is calculated: FVC% (T12)- FVC%(T0)).; In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%; Results are reported for participants with predicted FVC 50-80% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0	Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%.; FVC decline is calculated: FVC% (T12)- FVC%(T0)).; In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%; Results are reported for participants with predicted FVC > 80% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate the Quality of Life according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years).; The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate SGRQ according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years).; The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%; Results are reported for participants with predicted FVC<50% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).; FVC decline: FVC% (T12)- FVC%(T0); Results are reported for participants with predicted FVC 50-80% at baseline.	12 months (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life).; FVC decline: FVC% (T12)- FVC%(T0); Results are reported for participants with predicted FVC >80% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253); (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5%	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	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	Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).; The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health.; FVC decline: FVC% (T12)- FVC%(T0); In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years); The calculated variable was stratified into the following subgroups between T0 and T12: =-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC>80% at baseline.	12 months. (At baseline visit (T0) and at 12 month visit (T12)).
Secondary	Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire	Caregivers of IPF patients were asked to complete the Zarit Burden Interview. It is a self-report measure. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options, in the Spanish version, range from 0 (never) to 4 (nearly always).; The final score ranges from 0 to 88. A higher score implies a greater burden (= 21: Little or no burden; 22-40: mild to moderate burden; 41-60: moderate to severe burden; = 61: severe burden).	12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).

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