Clinical trial NCT03710824: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
Official title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months
timeFrame: At baseline and at 3 months.
measure: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months
timeFrame: At baseline and at 6 months.
measure: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months
timeFrame: At baseline and at 9 months.
measure: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months
timeFrame: At baseline and at 12 months.
Secondary outcomes:
measure: Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score
timeFrame: At baseline and at 3, 6, 9, and 12 months.
measure: Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)
timeFrame: At baseline, and at 3, 6, 9, and 12 months.
measure: Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: At 3, 6, 9, and 12 months.
measure: Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire
timeFrame: At baseline, and at 3, 6, 9, and 12 months.
measure: Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)
timeFrame: At baseline, and at 3, 6, 9, and 12 months.
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: University General Hospital of Evros
city: Athens
country: Greece
facility: Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, University Pulmonology Cl
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Kerkyra
country: Greece
facility: General Hospital of Kerkyra
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Patras
country: Greece
facility: Univ. Gen. Hosp. of Patras
city: Thessaloniki
country: Greece
facility: A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
Study officials:
References: