Clinical trial NCT03567785: Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Official title: Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis: the Key to Successful Treatment Outcomes: the SUPIRIO-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Keywords: Therapy adherence
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a recent diagnosis of IPF and starting on Pirfenidone at the University hospitals of Leuven will be invited to participate in the SUPIRIO study.

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.

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.

Primary outcomes:
measure: The prevalence of non-adherence to pirfenidone (=non-initiation, discontinuation and non-implementation).
timeFrame: 1 year
Secondary outcomes:
measure: Impact of medication non-adherence on the forced vital capacity (FVC).
timeFrame: 1 year
measure: Impact of medication non-adherence on progression-free survival.
timeFrame: 1 year
measure: Impact of medication non-adherence on quality of life measured with the EQ-5D-5L questionnaire.
timeFrame: 1 year
measure: Impact of health literacy on therapy adherence.
timeFrame: Baseline
measure: Impact of depression on therapy adherence
timeFrame: 1 year
measure: Impact of barriers on therapy adherence
timeFrame: 1 year
measure: Impact of medication non-adherence on quality of life measured with the K-BILD questionnaire.
timeFrame: 1 year
measure: Impact of medication non-adherence on quality of life measured with the SGRQ.
timeFrame: 1 year
measure: Impact of non-adherence on the diffusing capacity for carbon monoxide (DLco).
timeFrame: 1 year
measure: Adherence to Pirfenidone
timeFrame: 1 year
measure: Knowledge that patients have on their disease and treatment
timeFrame: 1 year
Other outcomes:
measure: Adherence to limited alcohol intake
timeFrame: 1 year
measure: Physical activity of patients
timeFrame: 1 year
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: BE
Study officials:
affiliation: Catholic University Leuven
name: Wim Wuyts
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.