Investigating the effectiveness of nebulised Pulmozyme (dornase alfa) in reducing inflammation in chronic airway disease

Phase 4

Completed

• Conditions: Chronic airway disease; Chronic Obstructive Pulmonary Disease (COPD); Asthma; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Asthma

• Registration Number: ACTRN12617000395336
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-17
• Study Completion: 2020-01-08
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Males and females aged >18 years with Doctor diagnosed stable COPD, confirmed by incompletely reversible airflow obstruction (post bronchodilator FEV1<80% predicted and FEV1/FVC<70%)
Males and females aged >18 years with Doctor diagnosed stable asthma
Non-smokers or ex-smokers (> 6 months since last cigarette).
High levels of sputum NETs (>20ng/uL eDNA, conducted in Aim 1) (determined after screening visit)

Exclusion Criteria

COPD or asthma exacerbation or respiratory tract infection (OCS or antibiotics), or change in maintenance therapy in the past 6 weeks (visit will be postponed)
Current smoking (last 6 months)
Any use of antibiotics in the past month (visit will be postponed)
Pregnancy or breastfeeding
Inability to attend clinic visits
Other significant illness likely to interfere with management or participation in the study
Participation in any other interventional research study in the last 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the level of extracellular DNA in sputum (picogreen assay)[Outcomes will be measured at baseline, at the start and completion of each treatment sequence.];The detection of neutrophil extracellular traps (NETs) using immunofluorescent staining of sputum smears[Outcomes will be measured at baseline, at the start and completion of each treatment sequence.]