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RESPIRE-ILD: NAC and Dexamethasone for Radiation Pneumonitis in ILD
NCT05986318Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Jul 2028
- Countries
- 1
- Modality
- Orthosteric Ligands
- Conditions
- radiation pneumonitis (RP)
01
Overview
Phase 2, randomised, double-blind trial of acetylcysteine and dexamethasone in radiation pneumonitis (RP) (4 arms). Primary endpoint: Rate of Grade 2-5 Dyspnea at 6 months. Started Jan 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
NAC + Corticosteroids
NAC 600 mg TID for 60 days + Dexamethasone tapered over 20 days + RT
Corticosteroids + NAC Placebo
NAC Placebo TID for 60 days + Dexamethasone tapered over 20 days + RT
NAC + Dexamethasone Placebo
NAC 600 mg TID for 60 days + Dexamethasone Placebo tapered over 20 days + RT
NAC Placebo + Dexamethasone Placebo
NAC Placebo TID for 60 days + Dexamethasone Placebo tapered over 20 days + RT
03
Who it enrols
Patients with lung cancer or oligometastatic pulmonary lesions and fibrotic interstitial lung disease planned for radical intent radiotherapy.
04
Endpoints
Primary
Rate of Grade 2-5 Dyspnea
Secondary
Patient Scored Dyspnea
Patient Scored Cough
Quality of Life Measured by FACT-L
Quality of Life Measured by EQ-5D-5L
Local Control
Progression Free Survival
Overall Survival
Cancer Specific Survival
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