Idiopathic Pulmonary FibrosisPNEUMONNCT03115619
Quality of Life Study in Participants With IPF Under Pirfenidone Treatment
An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 7 sites in Greece.
Trial summary
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- How many people
- 102 participants
- Where
- 7 sitesGreece
- Study dates
- 18 Apr 2017to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in Greece with IPF under treatment with pirfenidone.
Who may be able to join
- 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
Who cannot join
- Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Greece7 sites
Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
Athens, 115 27
University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
Chaïdári, 124 62
University General Hospital of Heraklio, Pulmonary Clinic
Heraklio, 711 10
University General Hospital of Ioannina
Ioannina, 455 00
General University Hospital of Larisa; Pneumonology Clinic
Larissa, 413 34
General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
Thessaloniki, 570 10
Papanikolaou Hospital; Pneumonology Clinic
Thessaloniki, 570 10
About this study
Official title: 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
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called Esbriet
Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).
| Study group | Role | What they receive |
|---|---|---|
| Participants With IPF | Observational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52). Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
Measured: Baseline, end of treatment (up to Week 52)
Secondary outcomes (7)
Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment
Measured: Baseline, end of treatment (up to Week 52)
Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment
Measured: Baseline, end of treatment (up to Week 52)
Change From Baseline in Annual FVC
Measured: From Baseline up to end of treatment (up to Week 52)
Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment
Measured: Baseline, end of treatment (up to Week 52)
Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization
Measured: from Baseline up to end of treatment (up to Week 52)
Percentage of Participants who are Compliant to Treatment
Treatment compliance will be assessed by the total number of dose reductions, dose interruptions, and the administered dosing intensity relative to the projected dose intensity during treatment.
Measured: From Baseline up to end of treatment (up to Week 52)
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests
Measured: From Baseline up to end of treatment (up to Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start18 Apr 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115619
- Sponsor's protocol ID
- ML39259
- Acronym
- PNEUMON
- Status last verified
- Aug 2020
- First submitted
- 12 Apr 2017
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03115619
- Acronym / sponsor ID
- PNEUMON / ML39259
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With IPF | – | Drug: PirfenidoneObservational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in Greece with IPF under treatment with pirfenidone.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidoneAlso: EsbrietParticipants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC). | Drug | Participants With IPF |
Primary outcome
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)
7 secondary outcomes
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)
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)
Change From Baseline in Annual FVC
Time frame: From Baseline up to end of treatment (up to Week 52)
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)
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)
Percentage of Participants who are Compliant to Treatment
Time frame: From Baseline up to end of treatment (up to Week 52)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 7 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.