Evaluate the Effect of Diet on Gastrointestinal Adverse Events in Patients With IPF Treated With Pirfenidone

NCT03539289 | Completed

• 2 other identifiers: MA39293-DIET2016-003827-45
• Study Type: interventional
• Target: 90
• Locations: 6 countries
• Sites: 6

Brief Summary

The primary objective is 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.

Conditions

Pulmonary Disease

Keywords

IPF; Mitigating Adverse Events

Outcome Measures

Primary Outcomes (1)

• Incidence of gastrointestinal AEs

  • To compare the incidence of gastrointestinal AEs in patients with IPF initiating pirfenidone for the first time - according to the type of diet (Monounsaturated Fatty Acids \[MUFA\] vs Saturated Fatty Acids \[SFA\]). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment

  First 16 weeks of pirfenidone treatment

Study Arms (2)

MUFA Diet

OTHER

Monounsaturated Fatty Acids Diet

Behavioral: MUFA Diet

SFA Diet

OTHER

Saturated Fatty Acids Diet

Behavioral: SFA Diet

Interventions

MUFA Diet BEHAVIORAL

Control of patient MUFA Diet

MUFA Diet

SFA Diet BEHAVIORAL

Control of patient SFA Diet

SFA Diet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Ability to comply with the study protocol in the opinion of the Investigator
• Age \> 40 years
• Naiive-treated patients with diagnosis of IPF at least 1 week but not more than 5 years prior to study baseline
• 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).
• 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 non-hormonal contraceptive method with a failure rate of \<1% per year during the Treatment Period and for at least 28 days after the last dose of study treatment
• 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

You may not qualify if:

• History of coexistent and clinically significant (in the opinion of the Investigator) chronic obstructive pulmonary disease (COPD), 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
• Expecting a lung transplant in \<12 months
• Certain laboratory abnormalities or findings at baseline, including:
• Total bilirubin \> 5 the upper limit of normal (ULN)
• AST/SGOT or ALT/SGPT \>1.5 ULN
• Alkaline phosphatase \>2.0 ULN
• 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 non-hormonal? contraceptive method

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (6)

University Hospital Essen

Essen, 45239, Germany

Location

University of Crete, Eraklion

Heraklion, 741 00, Greece

Location

Università de Catania

Catania, Sicily, 95123, Italy

Location

Erasmus MC, Rotterdam

Rotterdam, 3015, Netherlands

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Molina-Molina M, Shull JG, Vicens-Zygmunt V, Rivera-Ortega P, Antoniou K, Bonella F, Renzoni E, Russell AM, Maher TM, Vancheri A, Bachs A, Aviles V, Palma J, Bermudo G, Suarez-Cuartin G, Tebe C, Rigo-Bonnin R, Montes-Worboys A, Wijsenbeek M, Vancheri C. Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial. Eur Respir J. 2023 Oct 19;62(4):2300262. doi: 10.1183/13993003.00262-2023. Print 2023 Oct.

  PMID: 37857429 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• María Molina Molina

  Unidad Funcional de Intersticio Pulmonar (UFIP).Servicio de Neumología. Hospital Universitario de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: December 28, 2017
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

IT (1); NL (1); DE (1); ES (1); GB (1); GR (1)