- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03710824
Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib (QUALIFY IPF)
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alexandroupoli, Greece, 68100
- University General Hospital of Evros
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Athens, Greece, 11527
- Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
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Athens, Greece, 124 62
- University General Hospital ATTIKON
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Heraklion, Greece, 71100
- University Hospital of Heraklion, University Pulmonology Cl
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Ioannina, Greece, 45 500
- Univ. Gen. Hosp. of Ioannina
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Kerkyra, Greece, 49100
- General Hospital of Kerkyra
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Larissa, Greece, 41110
- General University Hospital of Larissa
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Patras, Greece, 26504
- Univ. Gen. Hosp. of Patras
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Thessaloniki, Greece, 57010
- General Hospital of Thessaloniki "G. Papanikolaou"
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Thessaloniki, Greece, 57010
- A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Subjects with Idiopathic Pulmonary Fibrosis
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diagnosed IPF patients initiating treatment with nintedanib
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline in Health Related Quality of Life (HRQoL) using SGRQ score
Time Frame: upto 52 weeks
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St. George's Respiratory Questionnaire (SGRQ)
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upto 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of mean change from baseline of dyspnoea burden with modified Medical Research Council scale (mMRC) score
Time Frame: upto 12 months
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modified Medical Research Council scale (mMRC)
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upto 12 months
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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
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Cough-Visual Analogue scale (cough-VAS)
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upto 12 months
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Percentage of adhered patients to nintedanib treatment with Simplified Medication Adherence Questionnaire (SMAQ)
Time Frame: upto 52 weeks
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adapted for the treatment of idiopathic pulmonary fibrosis (IPF)
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upto 52 weeks
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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
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Generalized Anxiety Disorder Screener (GAD-7) Questionnaire
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upto 52 weeks
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Percentage of patients that use LTOT
Time Frame: upto 52 weeks
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Long Term Oxygen Treatment (LTOT)
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upto 52 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1199-0355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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