Idiopathic Pulmonary Fibrosis MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ESBRIET
Product Name: ESBRIET
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PIRFENIDONE
CAS Number: 53179-13-8
Sponsors
CIBER - Instituto Carlos III
Institut d'Investigació Biomédica de Bellvitge (IDIBELL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form • Ability to comply with the study protocol in the opinion of the Investigator • Age > 40 years • Diagnosis of IPF at least 1 week prior to study baseline and no more than 5 years. • Confirmation of IPF diagnosis by the Investigator of each Centre, in accordance with the 2011 international consensus guidelines (Raghu et al. 2011), at baseline. • IPF that meet criteria for pirfenidone treatment initiation according to local reimbursement policy • Approval of potential study participation by Central Committee (FFQ shows a clear diet predominance, MUFA or SFA). Defined and regular diet for at least six months prior to baseline (i.e. no frequent changes in the type of diet). • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • History of coexistent and clinically significant (in the opinion of the Investigator) COPD (including chronic bronchitis, emphysema), bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF. • History of any connective tissue disease, including, but not limited to: rheumatoid arthritis, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, or mixed connective tissue disease • History of clinically significant environmental exposure to agents known to cause pulmonary fibrosis, including asbestos, beryllium, silica, and other occupational dusts; amiodarone, nitrofurantoin, and other drugs; radiation; and birds, feathers, molds, and other inhaled antigens known to cause hypersensitivity pneumonitis • Participation in any other investigational trial throughout the study • Any serious medical condition that, in the opinion of the Investigator, may pose an additional risk in administering study treatment to the patient • Certain laboratory abnormalities or findings at baseline, including: o Total bilirubin > 5 of the upper limit of normal (ULN) o AST/SGOT or ALT/SGPT >1.5 ULN o Alkaline phosphatase >2.0 ULN o Creatinine clearance <40 mL/min, calculated using the Cockcroft-Gault formula • Pregnant or lactating, or intending to become pregnant during the study • Pharmacological treatments (concomitant-therapy) at baseline that may cause patient gastrointestinal side effects • Major gastro-intestinal disorders at baseline (gastric or bowel surgery, ulcus). Patients with gastroesophagic reflux or other minor digestive disorders can be included. • Pregnant patients, or women of child-bearing potential, not using a reliable contraceptive method • Planning to change the type of diet in the next 4 months • Not able to follow a specific type of diet or cannot be allocated to a specific type of diet (MUFA vs SFA) by the Central Committee • Previous intolerance or allergy to pirfenidone or hypersensitivity to the active substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 16 weeks; Main Objective: • To compare the incidence of gastrointestinal AEs in patients treated with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment. Any gastrointestinal AE related to pirfenidone treatment, including nausea, diarrhea, dyspepsia, reflux, vomiting, stomach discomfort, and abdominal distension, will be studied. ; Secondary Objective: • To evaluate the characteristics of the patients in both arms, including associated epidemiological parameters • Severity (according to the Common Terminology Criteria {CTC} grading for Adverse Events version 4.0), frequency, duration of the gastrointestinal side effects, discontinuation of treatment, dose reduction and hospitalization due to these side effects. • Specific variables of the diet that may interfere in gastric treatment-emergent side effects: o Number of daily meals o Method of cooking the food o Use of butter/oil in cooking o Quantity and variety of foods • Other factors that may act on gastric function and drug absorption: weight, use of proton pump inhibitors (PPI), gastro-prokinetics (such as Cisapride, Domperidone, and Metoclopromide) ; Primary end point(s): • To compare the incidence of gastrointestinal AEs in patients treated with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment. Any gastrointestinal AE related to pirfenidone treatment, including nausea, diarrhea, dyspepsia, reflux, vomiting, stomach discomfort, and abdominal | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Baseline characteristics of MUFA and SFA subjects will be described and evaluated using mean and standard deviation for continuous symmetric variables, median and interquartile range (Q1-Q3) for non-symmetric variables and absolute and relative frequencies for categorical variables.;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Greece, Spain, United Kingdom
Contacts
Public ContactAlicia Navarro Cid
ALPHA BIORESEARCH- NEXT CRO MONEPE, UNIÓN TEMPORAL DE EMPRESAS, LEY 18/82
Outcome results
None listed