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

Idiopathic Pulmonary Fibrosis Clinical Trial

— QUALIFY IPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710824
• Other study ID #: 1199-0355
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: February 22, 2023

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 22, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Nintedanib
diagnosed IPF patients initiating treatment with nintedanib

Locations

Country	Name	City	State
Greece	University General Hospital of Evros	Alexandroupoli
Greece	Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.	Athens
Greece	University General Hospital Attikon	Athens
Greece	University Hospital of Heraklion, University Pulmonology Cl	Heraklion
Greece	Univ. Gen. Hosp. of Ioannina	Ioannina
Greece	General Hospital of Kerkyra	Kerkyra
Greece	General University Hospital of Larissa	Larissa
Greece	Univ. Gen. Hosp. of Patras	Patras
Greece	A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki	Thessaloniki
Greece	General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Health Related Quality of Life (HRQoL) using SGRQ score	St. George's Respiratory Questionnaire (SGRQ)	upto 52 weeks
Secondary	measurement of mean change from baseline of dyspnoea burden with modified Medical Research Council scale (mMRC) score	modified Medical Research Council scale (mMRC)	upto 12 months
Secondary	measurement of mean change form baseline to the follow up period of cough burden with Cough-Visual Analogue scale (cough-VAS)	Cough-Visual Analogue scale (cough-VAS)	upto 12 months
Secondary	Percentage of adhered patients to nintedanib treatment with Simplified Medication Adherence Questionnaire (SMAQ)	adapted for the treatment of idiopathic pulmonary fibrosis (IPF)	upto 52 weeks
Secondary	measurement of mean change of anxiety in IPF patients treated with nintedanib from baseline to follow up period via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire	Generalized Anxiety Disorder Screener (GAD-7) Questionnaire	upto 52 weeks
Secondary	Percentage of patients that use LTOT	Long Term Oxygen Treatment (LTOT)	upto 52 weeks

External Links

•   Related Info