Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

  • STATUS
    Recruiting
  • End date
    Mar 28, 2023
  • participants needed
    240
  • sponsor
    Boehringer Ingelheim
Updated on 16 January 2022
nintedanib
idiopathic pulmonary fibrosis

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.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment Nintedanib
Clinical Study IdentifierNCT03710824
SponsorBoehringer Ingelheim
Last Modified on16 January 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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