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

NCT03710824 | Completed Results FDA Drug

• 1 other identifier: 1199-0355
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (4)

• Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months

  St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.

  At baseline and at 3 months.

• Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months

  St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.

  At baseline and at 6 months.

• Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months

  St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.

  At baseline and at 9 months.

• Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months

  St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off \<70%), DLCOBSL (cut off \<40%), number of comorbidities and baseline score by visit interaction.

  At baseline and at 12 months.

Secondary Outcomes (5)

• Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score

  At baseline and at 3, 6, 9, and 12 months.

• Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)

  At baseline, and at 3, 6, 9, and 12 months.

• Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)

  At 3, 6, 9, and 12 months.

• Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire

  At baseline, and at 3, 6, 9, and 12 months.

• Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)

  At baseline, and at 3, 6, 9, and 12 months.

Study Arms (1)

Nintedanib for patients with Idiopathic Pulmonary Fibrosis

Drug: Nintedanib

Interventions

Nintedanib DRUG

diagnosed IPF patients initiating treatment with nintedanib

Nintedanib for patients with Idiopathic Pulmonary Fibrosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed IPF patients initiating treatment with nintedanib according to their physician's clinical decision will be enrolled in this study. In details, patients will be eligible to enroll in the study if the fulfil all the inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

University General Hospital of Evros

Alexandroupoli, 68100, Greece

Location

Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.

Athens, 11527, Greece

Location

University General Hospital Attikon

Athens, 124 62, Greece

Location

General Hospital of Kerkyra

Corfu, 49100, Greece

Location

University Hospital of Heraklion, University Pulmonology Cl

Heraklion, 71100, Greece

Location

Univ. Gen. Hosp. of Ioannina

Ioannina, 45 500, Greece

Location

General University Hospital of Larissa

Larissa, 41110, Greece

Location

Univ. Gen. Hosp. of Patras

Pátrai, 26504, Greece

Location

A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki

Thessaloniki, 57010, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Study is characterized by inherent limitations attributed to its non-interventional nature. Given that idiopathic pulmonary fibrosis (IPF) diagnosis was done by treating physician, substantial variability in diagnosis may exist. As patient reported outcomes (PROs) were utilized to evaluate, it is important to be aware of potential bias related to such subjective measures. Given the small numbers and heterogeneous population no comparisons / causal associations could be assessed in study.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: February 28, 2019
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

GR (10)