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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03115619 |
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Date of registration:
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12/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Quality of Life Study in Participants With IPF Under Pirfenidone Treatment
PNEUMON |
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Scientific title:
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A Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon Study |
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Date of first enrolment:
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April 18, 2017 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03115619 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult participants for whom pirfenidone has already been prescribed for IPF no more
than 4 weeks prior to enrollment, according to their physicians' clinical decision and
the terms in the SmPC
Exclusion Criteria:
- Participants who are participating in an interventional study or have received any
investigational agent in the past 4 weeks
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Pirfenidone
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Primary Outcome(s)
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Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
[Time Frame: Baseline, end of treatment (up to Week 52)]
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Secondary Outcome(s)
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Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment
[Time Frame: Baseline, end of treatment (up to Week 52)]
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Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment
[Time Frame: Baseline, end of treatment (up to Week 52)]
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Change From Baseline in Annual FVC
[Time Frame: From Baseline up to end of treatment (up to Week 52)]
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Percentage of Participants who are Compliant to Treatment
[Time Frame: From Baseline up to end of treatment (up to Week 52)]
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Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment
[Time Frame: Baseline, end of treatment (up to Week 52)]
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Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization
[Time Frame: from Baseline up to end of treatment (up to Week 52)]
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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests
[Time Frame: From Baseline up to end of treatment (up to Week 52)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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