Use of DNAse in Neutrophilic Asthma

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot protocol, the researchers look to determine benefits from use of nebulized rh-DNase for 4 weeks in patients with neutrophilic asthma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health

Criteria

Inclusion Criteria:

• i. Able to read and sign an Informed Consent Form (ICF)

• ii. At least Age 18

• iii. Diagnosis of Asthma with previous source documentation of PC 20 ≤ 16 mg/dl measured by FEV1 and/or reversibility with albuterol of ≥12% in FEV1

• iv. pre-bronchodilator Forced Vital Capacity (FVC) less than 85% predicted AND Serum total MMP9 ≥ 1800 (cut off determined by previous clinical investigation- Medimmune) OR serum IL-8> 20 pg/ml OR Sputum extracellular DNA ≥ 3.8 µg/mL OR Sputum Neutrophils > 40%

Exclusion Criteria:

• i. Pregnancy

• ii. Current smoker, smoking within the past year or pack/year history ≥ 10

• iii. Respiratory infection within past 6 weeks

• iv. Antibiotics within the past 4 weeks

• v. Active lung disease other than asthma

• vi. Cancer within the past 5 years (excluding basal cell skin cancer)

• vii. Chronic infection due to HIV, HBV, or HCV

• viii. Hematologic or autoimmune disease

• ix. Unable to safely undergo bronchoscopy as determined by primary or study doctor.