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Dornase Alfa Inhalant

Phase 3

Multiple Trauma | Small molecule | Respiratory |Pulmonx Corporation|Last Updated: Aug 20, 2026

Target and mechanism

ModalitySmall molecule

Also known as Dornase Alfa Inhalant Solution [Pulmozyme]

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

Dornase Alfa Inhalant · 1 trial · 2 indications

Phase 3 1
NCT03368092Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe TraumaMultiple Trauma
RECRUITING500 Analytics
PHASE3RECRUITING
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Multiple Trauma
NCT03368092500
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Study Endpoints

Primary Endpoints

The primary endpoint is the incidence of moderate to severe ARDS (PaO2/FiO2 < 200, according to the Berlin definition [ARDS definition task force et al. JAMA 2015; 307(23): 2526-2533]) in severe trauma patients (Injury Severity Score > 15).
Day 0 to Day 7

Secondary Endpoints

Static lung compliance [mL/cmH2O]
Day 0 to Day 7
Duration of mechanical ventilation [hours]
Day 0 to Day 7
Length of ICU stay [hours]
Day 0 to Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dornase alfaEXPERIMENTALDornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
PlaceboPLACEBO_COMPARATORNaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.

Interventions

NameTypeDescription
Dornase Alfa Inhalant Solution [Pulmozyme]DRUGDornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
PlacebosDRUGNaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult (\>18) patient of either sex affiliated to the National Health Service * Severe trauma patient (either blunt or penetrating), Injury Severity Score \> 15 * Under mechanical ventilation for an expected duration \> 48h * Admitted in the ICU * Signed informed conse...

Countries:France
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