Over 30,000 Americans suffer each year from pulmonary airleaks leading to collapsed lungs with painful, invasive treatments, and costly hospitalizations. Current treatments are not effective enough in controlling airleaks and medical providers are seeking new therapies. There is strong evidence that a locally delivered therapeutic via inhalation would have a major impact on reducing the burden of this disease by promoting closure of the airleak directly. However, there are no approved therapies to achieve the aim of quickly resolving airleaks via inhalation, and effective treatment remains a significant unmet need. Therefore, we are developing a minimally invasive inhaled aerosol that aims to seal an airleak quickly and efficiently in the lung to prevent painful procedures and costly hospitalizations. The goal of this Phase I project is to develop and test the feasibility and efficacy of our novel inhaled dry powder aerosol formulation using an in-vivo pulmonary airleak model. Successful completion of this Phase I effort will position us to demonstrate safety in an in-vivo toxicology study and prepare for a first-in-human clinical study. Translation of this technology into a clinically beneficial medical product has the potential to significantly improve the lives of patients with pulmonary airleaks.
Public Health Relevance Statement: Project Narrative Over 30,000 Americans suffer each year from airleaks leading to collapsed lungs with painful, invasive treatments, and costly hospitalizations. There is strong evidence that a locally delivered therapeutic would make a major impact on reducing the burden of this disease. Therefore, we are developing a minimally invasive inhaled aerosol that aims to quickly and efficiently seal an airleak in the lung to prevent painful and costly complications.
Project Terms: Acceleration; Aerosols; Air; Biopsy; Cadaver; cadaveric; cadavers; Chest Tubes; Clinical Research; Clinical Study; Coughing; Data Analyses; Data Analysis; data interpretation; Disease; Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Investigational Drugs; Investigational New Drugs; Excipients; Fibrinogen; Blood Coagulation Factor I; Blood Coagulation Factor One; Blood Factor One; Coagulation Factor I; Coagulation Factor One; Factor I; Factor One; Future; Patient Care; Patient Care Delivery; Glues; Goals; Grant; Growth; Generalized Growth; Tissue Growth; ontogeny; Hospitalization; Hospital Admission; Human; Modern Man; Lead; Pb element; heavy metal Pb; heavy metal lead; Lung; Lung Respiratory System; pulmonary; Lung diseases; Pulmonary Diseases; Pulmonary Disorder; disease of the lung; disorder of the lung; lung disorder; Nebulizer; nebulization; nebulize; Pain; Painful; Particle Size; Patients; Pharyngeal structure; Pharynx; Throat; Pneumothorax; pneumothorax disorder; Powder dose form; Powders; pressure; Production; Safety; seal; Suction; Mechanical Aspiration; Suction Drainage; Family suidae; Pigs; Suidae; Swine; porcine; suid; Technology; Testing; Thrombin; Thrombase; fibrinogenase; Time; Toxicology; Translations; translation; United States; Work; Caring; improved; Procedures; Pleurodesis; Peripheral; Site; Clinical; Phase; Medical; Hospitalization cost; Hospital Costs; Buccal Cavity; Buccal Cavity Head and Neck; Cavitas Oris; Mouth; Oral cavity; Therapeutic; Therapeutic Agents; Deposition; Deposit; Clinic; Techniques; System; meter; Thoracic Surgical Procedures; Thoracic Surgery; chest surgery; Benchmarking; Best Practice Analysis; benchmark; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; meetings; meeting; American; experience; success; Animal Model; Animal Models and Related Studies; model of animal; novel; new technology; novel technologies; Devices; Positioning Attribute; Position; Modeling; drug development; Provider; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; pharmaceutical; Pharmacologic Substance; preventing; prevent; Data; Dryness; in vivo; Personal Behavior; Personal Conduct; Characteristics; Process; pre-clinical; preclinical; cost; healing; burden of disease; disease burden; years of life lost to disability; years of life lost to disease; burden of illness; new drug treatments; new drugs; new pharmacological therapeutic; new therapeutics; new therapy; next generation therapeutics; novel drug treatments; novel drugs; novel pharmaco-therapeutic; novel pharmacological therapeutic; novel therapy; novel therapeutics; minimally invasive; effective treatment; effective therapy; Formulation; experiment; experimental research; experiments; experimental study; efficacy study; Inhaling; Inhalation; in vivo testing; in vivo evaluation; first in man; first-in-human; feasibility testing; pig model; piglet model; swine model; porcine model; comparison control; compare to control; manufacture
