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Use of DNAse in Neutrophilic Asthma

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ClinicalTrials.gov Identifier: NCT03994380
Recruitment Status : Unknown
Verified February 2020 by National Jewish Health.
Recruitment status was:  Recruiting
First Posted : June 21, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neutrophilic Asthma Drug: RhDNAse Inhalation Solution Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of DNAse in Neutrophilic Asthma
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
rhDNAse 2.5 mg nebulizer daily for 4 weeks
 Drug: RhDNAse Inhalation Solution
rhDNAse 2.5 mg nebulizer daily for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Lung Function [ Time Frame: 4 weeks ]
    FEV1

  2. Symptom Control [ Time Frame: 4 weeks ]
    Asthma Control Test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994380


Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Laurie Manka, MD    303-398-1355    mankal@njhealth.org   
Contact: Richard Martin, MD    303-398-1355      
Sponsors and Collaborators
National Jewish Health
More Information
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03994380    
Other Study ID Numbers: 3030005151
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases