interventional
N/A
1 country
2
To evaluate the effect of inhalative Alveofact® on the Forced Vital Capacity of IPF patients after treatment compared to placebo in the same patients
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2024
Actual (reported)The primary endpoint is the mean intra-individual difference in the percentage change in FVC from baseline to the end of each inhalation phase
Change in Total Lung Capacity (TLC) from baseline to the end of each inhalation phase
Change in Forced Expiratory Volume in one second (FEV1) from baseline to the end of each inhalation phase
Change in FEV1/FVC ratio
Change in parameters R5, R20, X5, RF and AX from oscillometry (IOS) from baseline to the end of each inhalation phase
Change in diffusion capacity for CO (TLCO), KCO from baseline to the end of each inhalation phase
Justus-Liebig-Universitaet Giessen
Giessen, 35392, Germany
Klinikum der Universitaet Muenchen AöR
Munich, 81377, Germany
Dr. Sandrine Oberwinkler
First Submitted
May 6, 2024
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