Idiopathic Pulmonary FibrosisNCT02552849
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 26 sites in Canada.
Trial summary
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 305 participants
- Where
- 26 sitesCanada
- Study dates
- 25 Apr 2013to 15 Aug 2017
- 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: Patients with Idiopathic Pulmonary Fibrosis (IPF)
Who may be able to join
- > or = 18 years of age
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF
Who cannot join
- Hypersensitivity to Esbriet (pirfenidone)
- Concomitant use of fluvoxamine
- Severe hepatic impairment or end-stage liver disease
- Severe renal impairment or end-stage renal disease requiring dialysis
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Canada26 sites
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2
South Health Campus/Alberta Health Services/ University of Calgary
Calgary, Alberta, T3M 1M4
Edmonton Respiratory Consultants & Edmonton Sleep Lab
Edmonton, Alberta, T5J 3S9
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
Kelowna Respiratory and Allergy Cllinic
Kelowna, British Columbia, V1W 1V3
Hotel Dieu Hospital
Kingston, Ontario, K7L 2V7
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
London, Ontario, N6C 2R5
Credit Valley Professional Building
Mississauga, Ontario, L5M 2V8
Clinique de pneumologie de Moncton Respiratory Clinic
Moncton, New Brunswick, E1C 5K4
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
Mainra Rajesh R, Respirology
North Vancouver, British Columbia, V7M 2H9
Oshawa Clinic
Oshawa, Ontario, L1H 1B9
Carling Respiratory Services
Ottawa, Ontario, K1Y 4G2
Dr. Marc Newton Respirology
Owen Sound, Ontario, N4K 3M6
Dr. Graham W. Bishop Clinic
Saint John, New Brunswick, E2M 5J7
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4
Synergy Respiratory Care
Sherwood Park, Alberta, T8H ON2
Professional Medical Corporation
St. John's, Newfoundland and Labrador, A1C 2H3
St. Clare'S Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 2S3
St. Paul's Hospital University of British Colambia Division of Hematology
Vancouver, British Columbia, V6Z 1Y6
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 5A6
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X-5A6
Winnipeg Clinic
Winnipeg, Manitoba, R3C ON2
About this study
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- No intervention
- 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.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Overall study | Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Observed Predicted Forced Vital Capacity
Measured: Up to 4 years
Secondary outcomes (8)
Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)
Measured: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)
Measured: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)
Measured: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)
Measured: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)
Measured: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Measured: Up to 4 years
Progression-Free Survival (PFS)
Measured: Up to 4 years
Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start25 Apr 2013
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
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
- 305 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
- NCT02552849
- Sponsor's protocol ID
- ML29808
- Status last verified
- Nov 2017
- First submitted
- 16 Sep 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
- ClinicalTrials.gov ID
- NCT02552849
- Acronym / sponsor ID
- ML29808
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2013 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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 is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall study | – | Other: No interventionSpecific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Idiopathic Pulmonary Fibrosis (IPF)
Key inclusion criteria (3 listed)
- > or = 18 years of age
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF
Key exclusion criteria (4 listed)
- Hypersensitivity to Esbriet (pirfenidone)
- Concomitant use of fluvoxamine
- Severe hepatic impairment or end-stage liver disease
- Severe renal impairment or end-stage renal disease requiring dialysis
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 |
|---|---|---|
| No intervention | Other | Overall study |
Primary outcome
Change in Observed Predicted Forced Vital Capacity
Time frame: Up to 4 years
8 secondary outcomes
Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)
Time frame: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)
Time frame: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)
Time frame: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)
Time frame: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)
Time frame: Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Time frame: Up to 4 years
Progression-Free Survival (PFS)
Time frame: Up to 4 years
Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)
Time frame: Up to 4 years
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 17 Nov 2017.
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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
26 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 26 sites in Canada.
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 3 inclusion and 4 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Canada. 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 in Observed Predicted Forced Vital Capacity (time frame: Up to 4 years). 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 17 Nov 2017.