A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
NCT06335303
Idiopathic Pulmonary Fibrosis, Lung Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT03770845
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.
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Observational
INRCA Casatenovo, Casatenovo, Lecco, Italy
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline (IPF diagnosis)
kg/m2
Time frame: baseline (IPF diagnosis)
kg/m2
Time frame: baseline (IPF diagnosis)
kg/m2
Time frame: baseline (IPF diagnosis)
kg/m2
Time frame: baseline (IPF diagnosis)
kg
Time frame: baseline (IPF diagnosis)
cm
Time frame: baseline (IPF diagnosis)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Time frame: baseline (IPF diagnosis)
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Time frame: 6 months after baseline
kg/m2
Time frame: 6 months after baseline
kg/m2
Time frame: 6 months after baseline
kg/m2
Time frame: 6 months after baseline
kg/m2
Time frame: 6 months after baseline
kg
Time frame: 6 months after baseline
cm
Time frame: 6 months after baseline
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Time frame: 6 months after baseline
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Time frame: baseline (IPF diagnosis) and 6 months after baseline
calcium level in plasma
Time frame: baseline (IPF diagnosis) and 6 months after baseline
vitamin D level in plasma
San Gerardo Hospital
Other
Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
Acronym: NUTRIPF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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