# Treating severe asthma in the small airways with a highly efficient and penetrating inhaled dry powder

> **NIH NIH R44** · QUENCH MEDICAL, INC. · 2020 · $1,247,479

## Abstract

Project Summary / Abstract
 Uncontrolled inflammation in the small airways remains a major unmet need in clinical pulmonology.
Severely asthmatic patients suffer from life-threatening symptoms and exacerbations requiring costly emergency
hospital treatments. Although asthma patients are prescribed large numbers of inhalers, these current devices
deliver very little medication into the lungs, with often less than 1% being deposited into small airways, which
remain untreated. Therefore, we are developing a new method of delivering medication to the small airways
which will perform significantly better than current products, including extra-fine formulations. We will create a
novel dry powder formulation containing budesonide, a well-studied and FDA approved corticosteroid medication
and a hygroscopic excipient (inactive ingredient) resulting in an excipient enhanced growth (EEG) formulation.
This EEG formulation will be able to uniquely treat inflammation in small airways in order to significantly reduce
related symptoms of severe asthma. By creating extra-fine submicron and micrometer sized drug powder
particles combined with a hygroscopic excipient, the particles are able to avoid depositing in the throat and grow
hygroscopically during inhalation to an optimal size to target the small airways with high efficiency. Hygroscopic
growth of the particles is essential to prevent exhalation of these small particles and to allow targeted deposition
in the small airways. The powder formulation will be delivered by a high efficiency dry powder inhaler including
a novel 3D rod array structure that was demonstrated to best disaggregate carrier-free powder formulations.
These new formulation and inhaler combinations have been shown to achieve emitted doses greater than 75%,
fine particle fractions (<5 µm in size) of greater than 90% and initial mass median aerodynamic diameters
(MMAD) less than 1.5 µm, which result in mouth-throat depositional losses of less than 5%. The high efficiency
drug delivery will increase drug deposition in untreated lung regions and reduce systemic drug exposure
compared to current devices, including extra-fine formulations. We have previously demonstrated feasibility by
manufacturing and testing a series of dry powder formulations for chemical stability, physicochemical
characteristics, and aerosol performance in a realistic airway in-vitro model in order to identify pharmaceutically
acceptable formulations. From these studies, we have selected the lead formulation to move forward in this
Phase II effort. We will produce adequate amounts of the lead formulation in order to conduct pre-clinical efficacy
tests and IND-enabling toxicology tests to demonstrate the safety of our novel budesonide formulation. Pre-
clinical proof of safety will allow for first-in-human testing, the next major phase of development toward
significantly controlling symptoms of severe asthma. The translation of this technology into a clinically beneficial
pr...

## Key facts

- **NIH application ID:** 10080247
- **Project number:** 1R44HL152780-01A1
- **Recipient organization:** QUENCH MEDICAL, INC.
- **Principal Investigator:** Bryce Beverlin II
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,247,479
- **Award type:** 1
- **Project period:** 2020-08-10 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080247

## Citation

> US National Institutes of Health, RePORTER application 10080247, Treating severe asthma in the small airways with a highly efficient and penetrating inhaled dry powder (1R44HL152780-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10080247. Licensed CC0.

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