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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT03710824
• Date of registration: 16/10/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib QUALIFY IPF
• Scientific title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
• Date of first enrolment: February 28, 2019
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03710824
• Study type: Observational

Countries of recruitment

Greece

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Nintedanib

Primary Outcome(s)

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

Secondary Outcome(s)

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 [Time Frame: upto 52 weeks]

Percentage of patients that use LTOT [Time Frame: upto 52 weeks]

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

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

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

Secondary ID(s)

1199-0355

Source(s) of Monetary Support

Please refer to primary and secondary sponsors