NCT03994380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 20, 2026

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

June 20, 2019

Last Update Submit

April 16, 2026

Conditions

Neutrophilic Asthma

Outcome Measures

Primary Outcomes (2)

  • Lung Function

    FEV1

    4 weeks

  • Symptom Control

    Asthma Control Test

    4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

rhDNAse 2.5 mg nebulizer daily for 4 weeks

Drug: RhDNAse Inhalation Solution

Interventions

RhDNAse Inhalation SolutionDRUG

rhDNAse 2.5 mg nebulizer daily for 4 weeks

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Interventions

dornase alfa

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 21, 2019

Study Start

February 12, 2020

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

April 20, 2026

Record last verified: 2020-02

Locations

US(1)