N/A
Completed N=180
Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
Source: ClinicalTrials.gov NCT03710824 ↗Enrolled (actual)
180
Serious AEs
5.6%
Results posted
Jul 2024
Primary outcomePrimary: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months — 2.08; -2.31; 3.37; 2.88 Score on a scale
Summary
Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months |
2.08; -2.31; 3.37; 2.88 | — |
| PRIMARY Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months |
3.55; -1.28; 4.18; 4.76 | — |
| PRIMARY Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months |
4.64; -1.07; 5.36; 6.09 | — |
| PRIMARY Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months |
6.00; -1.03; 6.19; 8.17 | — |
| SECONDARY Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score |
0.30; 0.31; 0.40; 0.39 | — |
| SECONDARY Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) |
-0.72; -3.73; -2.13; -1.25 | — |
| SECONDARY Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) |
70.75; 74.13; 75.18; 76.81 | — |
| SECONDARY Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire |
0.09; 0.48; 0.77; 0.97 | — |
| SECONDARY Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) |
17.78; 16.97; 16.34; 15.33; 15.44 | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥40 years of age.
- Patients that have signed Informed Consent Form.
- Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
- Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
- Patients that are able to read, understand and complete the study specific questionnaires.
Exclusion Criteria
- Treatment with nintedanib for more than 7 days prior to study enrolment.
- Patients receiving a combination therapy of nintedanib & pirfenidone for IPF.
- Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
- Prior treatment with pirfenidone or other treatment for IPF.
- Participation in an interventional study.
- Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.
Data sourced from ClinicalTrials.gov (NCT03710824). 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.