Stopped: Changing regulatory requirements requiring changes in study design. Participants were not enrolled
Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) - a portable, breath-actuated, digitally monitored system for precision delivery of inhaled agents with automated recording of inspiratory volume, flow, duration, and breath-hold parameters. Drug: 99mTc-DTPA (technetium-99m diethylenetriaminepentaacetic acid) - administered in aqueous solution (0.9% NaCl), radiolabeled for gamma scintigraphic imaging. Total dose: 500-800 µCi in 2 ml solution. Administration: Single-dose inhalation under supervision in a clinical setting.
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Segmental lung deposition of 99mTc-DTPA measured by planar gamma scintigraphy
Timeframe: Within 30 minutes post-inhalation
Incidence of treatment-emergent adverse events (TEAEs) assessed by clinical evaluation
Timeframe: Within 24 hours post-inhalation