phospholipid fraction, bovine lung for Idiopathic pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- IPF according to International Consensus Guidelines\n- Willingness of men and women of childbearing potential to use highly effective contraceptive methods\n- Forced Vital Capacity (FVC) > 75% predicted\n- Diffusion Capacity for CO (TLCO) > 40% predicted\n- Capillary pO2 > 60 mm Hg at rest\n- No need for supplemental oxygen at rest\n- Treatment-naive patients or patients treated with standard of care for more than 3 months. Treatment naive patients can only be included if they have previously failed on SOC medication. No standard of care medication will be withheld from participants of the study.\n- Patient must be ≥ 18 years old\n- Signed written informed consent\n- Ability and willingness to comply with study procedures"}

Exclusion criteria

• {"criterion_text":"- Current / previous exacerbation / respiratory infection within the last four weeks\n- Patients with known bronchial asthma\n- Simultaneous participation in another clinical trial with an experimental treatment\n- History of alcohol or drug abuse in the past year\n- Assessment by the investigator that the patient should not participate in the study if the patient is unlikely to be able to comply with the study procedures, limitations and requirements\n- Pregnancy or breastfeeding\n- Hypersensitivity to the active substance or any of the other ingredients\n- Concomitant emphysema > 15% of lung volume (by High Resolution Computed Tomography (HRCT))\n- Concomitant COPD with FEV1/FVC ratios < 70%\n- Concomitant malignant disease requiring therapy\n- Estimated life expectancy of less than 1 year for any reason\n- Renal insufficiency (GFR < 50% predicted and/or Crea > 2mg/dl)\n- Chronic liver cirrhosis > Child A\n- Any other liver disease with elevated ART/ARS >3 times the upper normal limit (UNL)\n- Any acute / chronic heart failure with ejection fraction of < 40%"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the mean intra-individual difference in the percentage change in FVC from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Mean intra-individual difference in percentage change in Forced Vital Capacity (FVC) comparing baseline to the end of each inhalation phase within the same patient."}

Secondary endpoints

• {"endpoint_text":"- Change in Total Lung Capacity (TLC) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in Total Lung Capacity (TLC)."}
• {"endpoint_text":"- Change in Forced Expiratory Volume in one second (FEV1) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in FEV1."}
• {"endpoint_text":"- Change in FEV1/FVC ratio","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in FEV1/FVC ratio."}
• {"endpoint_text":"- Change in parameters R5, R20, X5, RF and AX from oscillometry (IOS) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in oscillometry parameters R5, R20, X5, RF and AX measured by IOS."}
• {"endpoint_text":"- Change in diffusion capacity for CO (TLCO), KCO from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in diffusion capacity for CO (TLCO) and KCO."}
• {"endpoint_text":"- Change in arterial partial pressure of O2 (paO2) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in arterial paO2."}
• {"endpoint_text":"- Change in O2 saturation (SpO2) between rest and exercise (at the end of the 6MWT) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in SpO2 difference between rest and end of 6-minute walk test (6MWT)."}
• {"endpoint_text":"- Change in 6-minute walking distance (6MWT) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in distance achieved on 6MWT."}
• {"endpoint_text":"- Change in intratidal gas volume (ITV) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in intratidal gas volume (ITV)."}
• {"endpoint_text":"- Change in tidal impedance distribution (TID) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in tidal impedance distribution (TID)."}
• {"endpoint_text":"- Change in difference of TID over time (dTID) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in dTID (difference of TID over time)."}
• {"endpoint_text":"- Change in surface of ventilated areas (SURF) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in ventilated surface area (SURF)."}
• {"endpoint_text":"- Change in global inhomogeneity index (GI) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in global inhomogeneity index (GI)."}
• {"endpoint_text":"- Change in end-expiratory lung impedance (EELI) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in end-expiratory lung impedance (EELI)."}
• {"endpoint_text":"- Change in difference of EELI over time (dEELI) from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in dEELI (difference of EELI over time)."}
• {"endpoint_text":"- Assessment of toxicity and safety during the course of the study: AEs, SAEs","definition_or_measurement_approach":"Recording and assessment of adverse events (AEs) and serious adverse events (SAEs) during the study."}
• {"endpoint_text":"- Patient related outcome measures (PROMS): questionnaires KBILD, Leicester Cough and EQ-5D-5L from baseline to the end of each inhalation phase","definition_or_measurement_approach":"Change from baseline to end of each inhalation phase in patient-reported outcome measures (KBILD, Leicester Cough, EQ-5D-5L questionnaires)."}

Germany

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

672

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Philipps-Universitaet Marburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Ireland","full_name":"Aerogen Pharma Limited","duties_or_roles":"provide nebulizer","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Lyomark Pharma GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}