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Completed

NCT Number: NCT03710824

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University General Hospital of Evros, Alexandroupoli, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nintedanib

Drug

diagnosed IPF patients initiating treatment with nintedanib

Primary outcomes

  1. Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months

    Time frame: 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.

  2. Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months

    Time frame: 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.

  3. Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months

    Time frame: 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.

  4. Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months

    Time frame: 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 outcomes

  1. Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score

    Time frame: 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.

  2. Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)

    Time frame: 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.

  3. Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)

    Time frame: 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.

  4. 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: 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.

  5. Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)

    Time frame: At baseline, and at 3, 6, 9, and 12 months.

    Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Acronym: QUALIFY IPF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2018
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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