Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

NCT ID: NCT03567785

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2021-02-11

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is an irreversible, chronic and relentless lung disorder of unknown aetiology leading ultimately to respiratory insufficiency and death within 2-5 years after diagnosis. Treatment with the anti-fibrotic drug Pirfenidone slows down the disease progression and reduces the risk of acute exacerbations. Unfortunately, Pirfenidone represents a complex pharmacological regimen, in which patients have to take 3 tablets 3 times a day at mealtime. As for all chronically ill patients, adherence to a complex regimen might be challenging and nonadherence might reduce the full potential of Pirfenidone in patients with IPF. Due to extremely sparse availability of evidence on treatment adherence in the IPF population, it needs to be fully ascertained if, why, when and how many patients discontinue treatment or struggle to correctly take Pirfenidone as prescribed.

Detailed Description

Idiopathic pulmonary fibrosis (IPF) is an irreversible, chronic and relentless lung disorder of unknown aetiology characterised by a progressive destruction of lung parenchyma leading ultimately to respiratory insufficiency and death within 2-5 years after diagnosis. Treatment with the anti-fibrotic drug Pirfenidone slows down the disease progression and reduces the risk of acute exacerbations. Evidence also showed that treatment with Pirfenidone should be continued lifelong to maximise outcomes even in patients who experience disease progression during therapy. Unfortunately, Pirfenidone represents a complex pharmacological regimen, in which patients have to take 3 tablets 3 times a day at mealtime with a titration period in the first 3 weeks (i.e. 3 times 1 tablet of 267 mg during the first week, 3 times 2 tablets during the second week, and 3 times 3 tablets a week from week 3 onwards). As for all chronically ill patients, adherence to a complex regimen might be challenging and nonadherence might reduce the full potential of Pirfenidone in patients with IPF. Adherence is defined as "the extent to which a person' s behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider"(WHO, 2003) and encompasses three phases namely, initiation, implementation and persistence.

Due to extremely sparse availability of evidence on treatment adherence in the IPF population, it needs to be fully ascertained if, why, when and how many patients discontinue treatment or struggle to correctly take Pirfenidone as prescribed. Furthermore, the investigators also don't know what the impact is of non-adherence to Pirfenidone on clinical outcomes in patients with IPF and whether good adherence is associated with a better health related quality of life.

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of IPF based on the 2011 ATS/ERS/JRS/LATA diagnostic criteria
• Patients who will start treatment with pirfenidone
• Patients of 18 years or older
• Oral fluency in Dutch or French
• Being able to provide written informed consent

Exclusion Criteria

• Patients not managing their medications independently (e.g. Institutionalized patients, patients living in a nursing home or patients receiving homecare from a nurse). However, patients receiving help to prepare their medication from informal caregivers (i.e. family) are allowed to participate in the study.
• Patients not having their follow-up consultations at the University hospitals of Leuven.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Professor Wim Wuyts

Professor, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wim Wuyts

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven

Locations

University Hospitals Leuven

Leuven, BE, Belgium

Countries

Belgium

References

Delameillieure A, Dobbels F, Fieuws S, Leceuvre K, Vanderauwera S, Wuyts WA. Behavioural and psychological patterns of patients with idiopathic pulmonary fibrosis: a prospective study. Respir Res. 2022 May 14;23(1):124. doi: 10.1186/s12931-022-02041-6.

Reference Type: DERIVED

PMID: 35568881 (View on PubMed)

Other Identifiers

S61427

Identifier Type: -

Identifier Source: org_study_id