Condition category
Respiratory
Date applied
29/08/2019
Date assigned
13/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Idiopathic pulmonary fibrosis (IPF) involves scarring of the lungs, causing shortness of breath and coughing. Its cause is currently unknown. Pirfenidone is a drug used to treat IPF by slowing down the scarring and reducing inflammation. This study aims to investigate whether a patient assistance program designed for people with IPF who are being prescribed pirfenidone can increase the effect of the drug on their symptoms and improve their quality of life. The patient assistance program will include information on IPF and pirfenidone, as well as information on how to recognise and prevent side effects of treatment.

Who can participate?
Adults with IPF who have decided with their doctor to start taking pirfenidone.

What does the study involve?
When a patient goes to the hospital pharmacy to collect the pirfenidone prescribed by the lung specialist, he/she will be included by the healthcare professional in the study after signing the informed consent form and confirming they are eligible. Patients eligible to enter the study will be consecutively assigned to enter the assistance program (PAP group) or continue being followed as per Standard of Care (Control group) for a minimum of 6 months. Patients in the PAP group will be periodically contacted by specialized nurses in a call center. Control group patients will continue accessing the routine standard of care from their lung specialist and other healthcare professionals involved in the management of patients with IPF.

What are the possible benefits and risks of participating?
There are no additional risks, as the participant has already decided to start taking pirfenidone and it is their decision whether to take it, whether they participate in the trial or not. The potential benefit is that those in the patient assistance program might gain a greater understanding of their condition and how to manage it.

Where is the study run from?
Roche Farma (Spain)

When is the study starting and how long is it expected to run for?
January 2019 to July 2022

Who is funding the study?
Roche Farma (Spain)

Who is the main contact?
Roche Clinical Trials Enquiries
global-roche-genentech-trials@gene.com

Trial website

Contact information

Type

Public

Primary contact

Dr Clinical Trials

ORCID ID

Contact details

Ribera del Loira
50
Madrid
28042
Spain
+34 (0)91 3248100
global-roche-genentech-trials@gene.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ML40261

Study information

Scientific title

Impact of a patient assistance program on the persistence of treatment with pirfenidone in patients with idiopathic pulmonary fibrosis

Acronym

Study hypothesis

This non-interventional study will be conducted in Spain focusing on understanding the impact of a patient assistance program (PAP) on IPF participants.

Ethics approval

Approved 24/09/2018, Comité de Ética de la Investigación con medicamentos del Principado de Asturias (Hospital Universitario Central de Asturias, Avda. de Roma, s/n 33011 Oviedo, Spain; +34 9851079 27 ext. 37927/38028; ceim.asturias@asturias.org), ref: 48/18

Study design

Single-country prospective primary data collection non-interventional study (NIS)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Idiopathic pulmonary fibrosis

Intervention

The patients are not assigned to the treatment by the protocol but clinical practice and following the SmPC and clinical practice for dosing in both arms.

When a patient goes to the hospital pharmacy to collect the pirfenidone prescribed by the pulmonologist, he/she will be included by the healthcare professional (HP) in the study after signing the informed consent form and confirm the eligibility criteria. Patients eligible to enter the study will be consecutively assigned by a computer-generated algorithm in a 1:1 ratio to enter the assistance program (PAP group) or continue being followed as per Standard of Care (Control group) for a minimum of 6 months.

PAP group: patients in the PAP group will be periodically contacted by specialized nurses in a call center.
Control group: patients in the control group will continue accessing the routine standard of care from their pulmonologist and other HPs involved in the management of patients with IPF.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Time in days to permanent discontinuation of pirfenidone (i.e. time on pirfenidone) in participants allocated in PAP compared with participants who continue being followed-up as per the routine standard of care (SoC) up to 27 months

Secondary outcome measures

1. Percentage of participants who discontinue pirfenidone within the first 6 months of treatment up to 27 months]
2. Reasons for discontinuing pirfenidone: type and severity of adverse events (AEs) related to IPF treatment, type and severity of AEs unrelated to IPF treatment, worsening symptoms, physician’ s decision, patient’s decision, any other reason from baseline up to 27 months
3. Time and number of temporary interruptions of pirfenidone when they are communicated within the study duration from baseline up to 27 months
4. Time and number of dose-adjustments of pirfenidone (i.e. dose reductions) as per SmPC from baseline up to 27 months
5. Titrated-dose and full-dose of pirfenidone measured in mg from baseline up to 27 months
6. Adherence to pirfenidone measured by Morisky-Green (MG) questionnaire and by counting returned medication every month from baseline up to 27 months
7. Factors predicting adherence to and discontinuation of pirfenidone measured by patient activation measure (PAM) questionnaire at the inclusion and final visits from baseline up to 27 months
8. The role of psycho-morbidity (symptoms of depression and anxiety) on adherence to and discontinuation of pirfenidone measured by hospital anxiety and depression scale (HADS) score from baseline up to 27 months
9. Number and reasons for hospitalizations from baseline up to 27 months
10. Percentage of participants with adverse events (AE) from baseline up to 27 months
11. Functional respiratory changes of participants measured by forced vital capacity (FVC; absolute and % of predicted value), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, diffusing capacity of the lungs for carbon monoxide (DLCO, percentage of predicted value), and distance on 6-min walking test (6MWT) at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
12. Degree of dyspnea and fatigue after the administration of pirfenidone measured by modified Medical Research Council (mMRC) and Fatigue Assessment Scale (FAS) score, respectively, at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
13. Severity of cough after the administration of pirfenidone measured by Visual Analog Scale (VAS) score at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
14. Quality of life of participants measured by King’s Brief Interstitial Lung Disease (K-BILD) score at baseline and at last study visit
15. Satisfaction of participants with PAP measured by a 5-point Likert scale at the last study visit
16. Time-dependent impact of PAP on persistence rate of pirfenidone measured by the percentage of participants in the PAP group that remain on pirfenidone at different time-points from baseline, up to 27 months

Overall trial start date

30/01/2019

Overall trial end date

15/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participants diagnosed with idiopathic pulmonary fibrosis
2. Participants in whom their treating physician has decided, in partnership with them, to prescribe pirfenidone in accordance with the approved labelling
3. Written informed consent provided

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

189

Participant exclusion criteria

1. Concurrent participation in a clinical trial
2. Participants unable to give consent as per investigator criteria

Recruitment start date

14/03/2019

Recruitment end date

15/11/2021

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitari Germans Trias i Pujol; Servicio de Neumologia
Badalona
8916
Spain

Trial participating centre

Hospital General de Albacete; Servicio de Neumologia
Albacete
2008
Spain

Trial participating centre

Hospital del Mar; Servicio de Neumologia
Barcelona
8003
Spain

Trial participating centre

Hospital General de Granollers; Servicio de Neumologia
Granollers
8402
Spain

Trial participating centre

Hospital de Cruces; Servicio de Neumologia
Barakaldo
48903
Spain

Trial participating centre

Hospital Lucus Augusti; Servicio de Neumologia
Lugo
27003
Spain

Trial participating centre

Hospital de Mataro; Servicio de Neumologia
Mataro
8304
Spain

Trial participating centre

Corporacio Sanitaria Parc Tauli; Servicio de Neumologia
Sabadell
8208
Spain

Trial participating centre

Hospital Arnau de Vilanova de Lleida; Servicio de Neumologia
Lleida
25198
Spain

Trial participating centre

Complejo Hospitalario de Pontevedra; Servicio de Neumologia
Pontevedra
36164
Spain

Trial participating centre

Hospital Universitario de Fuenlabrada; Servicio de Neumologia
Fuenlabrada
28942
Spain

Trial participating centre

Fundacion Hospital Alcorcon; Servicio Neumologia
Alcorcon
28992
Spain

Sponsor information

Organisation

F. Hoffmann-La Roche AG

Sponsor details

Grenzacherstarsse 124
Basel
4070
Switzerland
+41 (0)61 688 1111
global-roche-genentech-trials@gene.com

Sponsor type

Industry

Website

https://www.roche.com/about/business/roche_worldwide.htm

Funders

Funder type

Industry

Funder name

F. Hoffmann-La Roche

Alternative name(s)

Hoffman-La Roche, F. Hoffmann-La Roche Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

Switzerland

Results and Publications

Publication and dissemination plan

Publication is planned in a peer-reviewed journal. There is no current plan to make additional study documents available.

IPD sharing statement
Participant-level data will not be available because it is confidential, proprietary information. Study data will be held at Roche Pharma S.A.

Intention to publish date

15/07/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/09/2019: Trial's existence confirmed by the Comité de Ética de la Investigación con medicamentos del Principado de Asturias.