N/A
N=204
OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03386994 ↗Enrolled (actual)
204
Serious AEs
15.2%
Results posted
Oct 2020
Primary outcome: Primary: Idiopathic Pulmonary Fibrosis (IPF)-Related Costs — 38923.57; 22613.68; 20369.94; 37183.17 Euro (€) — p=0.0002
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Idiopathic Pulmonary Fibrosis (IPF)-Related Costs |
38923.57; 22613.68; 20369.94; 37183.17; 22425.64; 20195.31 | 0.0002 sig |
| SECONDARY Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ) |
48.52; 33.70; 31.97; 43.34; 33.84; 30.68 | 0.0020 sig |
| SECONDARY Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS) |
58.41; 64.82; 66.67; 59.29; 65.16; 68.76 | 0.1560 |
| SECONDARY Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index |
92.95; 97.50; 97.67; 91.25; 95.94; 96.35 | 0.0075 sig |
| SECONDARY Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year |
6; 13; 3 | 0.0333 sig |
| SECONDARY Total Annual Acute Exacerbation-related Costs |
600.40; 819.28; 142.17 | — |
| SECONDARY Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group |
22261.30; 20986.06; 26171.47; 21926.97; 20939.38; 25818.15 | 0.4711 |
| SECONDARY Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 |
48035.14; 45646.56; 2388.58; 0.00 | — |
| SECONDARY Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0 |
24208.51; 20546.19; 23539.60; 23826.41; 20490.53; 23450.00 | 0.7486 |
| SECONDARY Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 |
8630.88; 23273.38; 23810.32; 8630.88; 23273.38; 23576.99 | 0.1581 |
| 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 |
8.49; 3.20; 0.23 | 0.0733 |
| 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 |
-14.93 | — |
| 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 |
12.58; 2.20; 2.16 | 0.0207 sig |
| 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 |
-11.97; 8.43; 0.56 | 0.0942 |
| 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 |
-8.96; -6.16; -0.04 | 0.0747 |
| 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 |
13.89 | — |
| 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 |
-10.48; -6.96; -1.45 | 0.1282 |
| 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 |
1.67; -2.00; -2.92 | 0.7471 |
| SECONDARY Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire |
23.59; 22.50; 22.08 | — |
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
Data sourced from ClinicalTrials.gov (NCT03386994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.