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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03710824
• Collaborator: (none)
• Enrollment: 180
• Locations: 10
• Anticipated Duration (Months): 48.9
• Patients Per Site: 18
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: Nintedanib

Study Design

• Study Type: Observational
• Actual Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
• Actual Study Start Date: Feb 28, 2019
• Anticipated Primary Completion Date: Mar 28, 2023
• Anticipated Study Completion Date: Mar 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Subjects with Idiopathic Pulmonary Fibrosis	Drug: Nintedanib; diagnosed IPF patients initiating treatment with nintedanib

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline in Health Related Quality of Life (HRQoL) using SGRQ score [upto 52 weeks]

   St. George's Respiratory Questionnaire (SGRQ)

Secondary Outcome Measures

1. measurement of mean change from baseline of dyspnoea burden with modified Medical Research Council scale (mMRC) score [upto 12 months]

   modified Medical Research Council scale (mMRC)

2. measurement of mean change form baseline to the follow up period of cough burden with Cough-Visual Analogue scale (cough-VAS) [upto 12 months]

   Cough-Visual Analogue scale (cough-VAS)

3. Percentage of adhered patients to nintedanib treatment with Simplified Medication Adherence Questionnaire (SMAQ) [upto 52 weeks]

   adapted for the treatment of idiopathic pulmonary fibrosis (IPF)

4. 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 [upto 52 weeks]

   Generalized Anxiety Disorder Screener (GAD-7) Questionnaire

5. Percentage of patients that use LTOT [upto 52 weeks]

   Long Term Oxygen Treatment (LTOT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital of Evros	Alexandroupoli		Greece	68100
2	Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.	Athens		Greece	11527
3	University General Hospital Attikon	Athens		Greece	124 62
4	University Hospital of Heraklion, University Pulmonology Cl	Heraklion		Greece	71100
5	Univ. Gen. Hosp. of Ioannina	Ioannina		Greece	45 500
6	General Hospital of Kerkyra	Kerkyra		Greece	49100
7	General University Hospital of Larissa	Larissa		Greece	41110
8	Univ. Gen. Hosp. of Patras	Patras		Greece	26504
9	A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki	Thessaloniki		Greece	57010
10	General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki		Greece	57010

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03710824
• Other Study ID Numbers: 1199-0355
• First Posted: Oct 18, 2018
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Nintedanib

Study Results

No Results Posted as of Aug 23, 2022