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Use of DNAse in Neutrophilic Asthma

CompletedPhase 1, Phase 2

Sponsor: National Jewish Health

Conditions: Neutrophilic Asthma

Interventions: RhDNAse Inhalation Solution

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Denver, Colorado, United States