Use of DNAse in Neutrophilic Asthma

Neutrophilic Asthma Clinical Trial

Official title:

Use of DNAse in Neutrophilic Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03994380
• Other study ID #: 3030005151
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 12, 2020
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Neutrophilic Asthma

Intervention

Drug:
• RhDNAse Inhalation Solution
rhDNAse 2.5 mg nebulizer daily for 4 weeks

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function	FEV1	4 weeks
Primary	Symptom Control	Asthma Control Test	4 weeks