Use of DNAse in Neutrophilic Asthma

NCT ID: NCT03994380

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2020-12-31

Brief 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.

Detailed Description

Patients with asthma of a non-Th2 phenotype have few advanced therapeutic options if their asthma remains poorly controlled despite adherence to guideline-based therapy. Currently, no targeted biologic therapies are available for neutrophilic asthma. The role of Recombinant human deoxyriboneuclease (rhDNase) has not been investigated in refractory asthma. rhDNase cleaves extracellular DNA released by neutrophils and other granulocytes, thereby reducing the viscosity of mucus. It is known that patients with asthma have higher levels of extracellular DNA than normals; however, these levels are lower than DNA levels found in the sputum of patients with cystic fibrosis. The benefits of rhDNase in cystic fibrosis have been well described. In these patients, use of daily nebulized rhDNase has shown improvement in lung function and reduction in exacerbations. Very little is known about DNAse use in asthmatics. Case reports have shown benefit when used in acute asthma exacerbations, but there are no data on its use as a therapy for neutrophilic asthma.

Conditions

Neutrophilic Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

rhDNAse 2.5 mg nebulizer daily for 4 weeks

Group Type: EXPERIMENTAL

RhDNAse Inhalation Solution

Intervention Type: DRUG

rhDNAse 2.5 mg nebulizer daily for 4 weeks

Interventions

RhDNAse Inhalation Solution

rhDNAse 2.5 mg nebulizer daily for 4 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Jewish Health

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Laurie Manka, MD

Role: primary

mankal@njhealth.org

303-398-1355

Richard Martin, MD

Role: backup

303-398-1355

Other Identifiers

3030005151

Identifier Type: -

Identifier Source: org_study_id