OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Registration Number: NCT03386994

Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 204

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

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs	12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).	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.

Secondary Outcome Measures

Name	Time	Method
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)).	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.
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
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)).	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.
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)).	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.
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
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)).	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.
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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%
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	12 months (At baseline visit (T0) and at 12 month visit (T12)).	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.
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
Total Annual Acute Exacerbation-related Costs	12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).	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.
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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%
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire	12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).	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).
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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%
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	12 months. (At baseline visit (T0) and at 12 month visit (T12)).	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.

Trial Locations

Locations (31): Hospital Clínico Universitario de Valladolid
🇪🇸
Valladolid, Spain
H. de Manacor
🇪🇸
Mallorca, Spain
Hospital Costa del Sol
🇪🇸
Marbella (Málaga), Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸
Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸
Majadahonda (Madrid), Spain
Hospital Regional Universitario de Málaga
🇪🇸
Málaga, Spain
H. Mateu Orfila
🇪🇸
Menorca, Spain
CHU de Ourense
🇪🇸
Ourense, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸
Santiago de Compostela, Spain
Hospital Universitari Son Espases
🇪🇸
Palma de Mallorca, Spain
Hospital Universitario Donostia
🇪🇸
San Sebastián, Spain
Hospital Sierrallana y Tres Mares
🇪🇸
Torrelavega (Cantabria), Spain
Hospital Montecelo
🇪🇸
Mourente (Pontevedra), Spain
H. Central de Asturias
🇪🇸
Oviedo, Spain
H. Son Llatzer
🇪🇸
Mallorca, 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. Vall d'Hebron
🇪🇸
Barcelona, Spain
H. U. Germans Trias i Pujol
🇪🇸
Barcelona, Spain
Hospital General Universitario de Castellón
🇪🇸
Castellón de la Plana, Spain
Hospital Universitario de Burgos
🇪🇸
Burgos, Spain
Hospital General Universitario Santa Lucía
🇪🇸
Cartagena (Murcia), Spain
H. U. de Girona Doctor Josep Trueta
🇪🇸
Girona, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸
Granada, Spain
H. Clínico San Carlos
🇪🇸
Madrid, Spain
Can Misses
🇪🇸
Ibiza, Spain
Hospital Universitario Lucus Augusti
🇪🇸
Lugo, Spain
Hospital Miguel Servet
🇪🇸
Zaragoza, Spain

OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

Recruitment & Eligibility

Study & Design

Trial Locations

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