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

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib

Registration Number: NCT03710824

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nintedanib for patients with Idiopathic Pulmonary Fibrosis	Nintedanib	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months	At baseline and 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months	At baseline and 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months	At baseline and 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.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months	At baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)	At 3, 6, 9, and 12 months.	SMAQ consisted of 6 items of which, four were dichotomous (Yes/No), one was Likert-type and one was an open question. A patient was considered as non-adherent, if he/she gave a positive response to any of the qualitative questions, and in terms of quantification, if the patient had lost one of the two daily doses for more than 2 days or had not taken medication for more than four complete days during the past 3 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.	Generalized Anxiety Disorder Screener (GAD-7) is a 7-item instrument validated for anxiety evaluation that could be used in an outpatient setting. Patients were asked at all study visits to indicate how often they experienced anxiety symptoms over the previous two weeks on a 4-point Likert scale as follows: 0 = 'not at all'; 1 = 'several days'; 2 = 'more than half the days'; and 3 = 'nearly every day'. 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.
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.	The modified Medical Research Council (mMRC) consists of a 5-level rating scale (grades 0-4) based on the patient's perception of dyspnoea (perception of breathlessness) in daily activities, with grade 4 representing the most severe category. 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.
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.	Patients were asked at each study visit to rate their perceived intensity of cough due to their IPF on a vertical VAS ranging from 0 to 100, with endpoints labelled as 'no cough' ('100'), 'moderate cough' ('50'), and 'intense cough' ('0'). 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.
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)	At baseline, and at 3, 6, 9, and 12 months.	Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented.

Trial Locations

Locations (10): University Hospital of Heraklion, University Pulmonology Cl
🇬🇷
Heraklion, Greece
Univ. Gen. Hosp. of Ioannina
🇬🇷
Ioannina, Greece
Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
🇬🇷
Athens, Greece
Univ. Gen. Hosp. of Patras
🇬🇷
Patras, Greece
University General Hospital of Evros
🇬🇷
Alexandroupoli, Greece
University General Hospital Attikon
🇬🇷
Athens, Greece
A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
🇬🇷
Thessaloniki, Greece
General Hospital of Kerkyra
🇬🇷
Kerkyra, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷
Thessaloniki, Greece
General University Hospital of Larissa
🇬🇷
Larissa, Greece