Nutritional Assessment in Idiopathic Pulmonary Fibrosis

Study Purpose

In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients. Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - age greater than or equal to 18 years; - diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion

    Exclusion Criteria:

    - severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min; - NYHA class IV; - severe liver failure, defined as Child-Pugh score class C; - active solid or haematological neoplasms; - having already received (currently or in the past) therapy with pirfenidone or nintedanib; - inability to walk without help; - need for oxygen therapy at rest; - participation in other interventional experimental protocols with use of a medicinal product.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03770845
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

San Gerardo Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data regarding this subject are available for patients with IPF. Primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity. Secondary aims of this study are:

  • - the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy.
  • - the assessment of calcium and vitamin D metabolism, by blood sampling, in patients diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

INRCA Casatenovo, Casatenovo, Lecco, Italy

Status

Recruiting

Address

INRCA Casatenovo

Casatenovo, Lecco,

Site Contact

Alessia Fumagalli

A.FUMAGALLI@inrca.it

03992321

San Gerardo Hospital, Monza, MB, Italy

Status

Recruiting

Address

San Gerardo Hospital

Monza, MB, 20900

Site Contact

Paola Faverio, MD

paola.faverio@unimib.it

+39 039233 #9040

G. Salvini Hospital, Garbagnate Milanese, Milano, Italy

Status

Recruiting

Address

G. Salvini Hospital

Garbagnate Milanese, Milano,

Site Contact

Francesco Bini

francesco_bini@hotmail.com

02994301

Ospedale di Circolo, Busto Arsizio, Varese, Italy

Status

Recruiting

Address

Ospedale di Circolo

Busto Arsizio, Varese,

Site Contact

Giulia Suigo

giusuigo@gmail.com

0331699111

Ospedale SS. Annunziata, Chieti, Italy

Status

Not yet recruiting

Address

Ospedale SS. Annunziata

Chieti, ,

Site Contact

Stefano Marinari

marinaristefano@gmail.com

08713571

San Martino Hospital, Genova, Italy

Status

Recruiting

Address

San Martino Hospital

Genova, ,

Site Contact

Emanuela Barisione

emanuela.barisione@hsanmartino.it

0105551

San Giuseppe Hospital, Milan, Italy

Status

Recruiting

Address

San Giuseppe Hospital

Milan, ,

Site Contact

Sergio Harari

sergio@sergioharari.it

0285991

San Paolo and San Carlo Hospital, Milan, Italy

Status

Recruiting

Address

San Paolo and San Carlo Hospital

Milan, ,

Site Contact

Michele Mondoni

michele.mondoni@asst-santipaolocarlo.it

0281841

Ospedale Maggiore Novara, Novara, Italy

Status

Recruiting

Address

Ospedale Maggiore Novara

Novara, ,

Site Contact

Roberta Nicali

roberta.nicali@libero.it

03213731

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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