AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003827-45-GB
• Lead Sponsor: CIBER - Instituto Carlos III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 90

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 <1% per year during the Treatment Period and for at least 58 days after the last dose of study treatment
oA woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
oExamples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
oThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
•For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
oWith female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the Treatment Period and for at least 118 days after the last dose of trial treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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:
oTotal bilirubin > 5 of the upper limit of normal (ULN)
oAST/SGOT or ALT/SGPT >1.5 ULN
oAlkaline phosphatase >2.0 ULN
oCreatinine 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified