N/A
Completed N=172
Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain
Source: ClinicalTrials.gov NCT03281200 ↗Enrolled (actual)
172
Serious AEs
7.6%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) — 57.0; 38.4; 4.7 Percentage of Patients (%)
Summary
The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) |
57.0; 38.4; 4.7 | — |
| PRIMARY Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)) |
42.5; 35.3; 22.2 | — |
| SECONDARY The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation |
70.1 | — |
| SECONDARY The Clinical Baseline Characteristics - Duration of the Disease |
1.5 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With Emphysema |
84.3; 15.7 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern |
13.4; 30.8; 55.8 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern |
9.9; 89.0; 1.2 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV® |
88.4; 11.0; 0.6 | — |
| SECONDARY The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy |
77.1 | — |
| SECONDARY The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy |
164.5 | — |
| SECONDARY The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy |
28.4 | — |
| SECONDARY The Demographic Baseline Characteristics - 6-minute Walk Test |
421.7 | — |
| SECONDARY The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit |
33.1; 64.0; 2.9 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea |
5.2; 93.0; 1.7 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations |
84.9; 11.6; 3.5 | — |
| SECONDARY The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments |
20.3; 79.7 | — |
| SECONDARY Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. |
45.9; 42.4; 25.6; 19.8; 15.7; 15.7 | — |
| SECONDARY Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation. |
41.9 | — |
| SECONDARY Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC) |
33.1; 62.2; 4.7 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is at least 18 years old
- The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management [5]
- The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC)
Exclusion Criteria
- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.
Data sourced from ClinicalTrials.gov (NCT03281200). 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. Informational only — not medical advice.