A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® / Zemaira® Weekly Intravenous Infusions Administered over 3 Years as Longterm Maintenance Therapy in Adult Subjects with Emphysema Related to Alpha1 Antitrypsin Deficiency

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522964-33-00

Enrollment

Registered

2026-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha1 antitrypsin deficiency, Alpha1-proteinase inhibitor deficiency, Emphysema

Brief summary

Annual rate of change in adjusted lung density

Detailed description

1. Annual rate of change in forced expiratory volume in 1 second percent predicted (FEV1%) 2. Annual rate of change in diffusion capacity of carbon monoxide (DLco) 3. Number of severe pulmonary exacerbations 4. Duration of severe pulmonary exacerbations 5. Number of participants experiencing treatment emergent adverse events (TEAEs) 6. Percentage of participants experiencing TEAEs

Interventions

DRUGRespreeza 4

DRUG000 mg powder and solvent for solution for infusion.

DRUGRespreeza 1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annual rate of change in adjusted lung density	—

Secondary

Measure	Time frame
1. Annual rate of change in forced expiratory volume in 1 second percent predicted (FEV1%) 2. Annual rate of change in diffusion capacity of carbon monoxide (DLco) 3. Number of severe pulmonary exacerbations 4. Duration of severe pulmonary exacerbations 5. Number of participants experiencing treatment emergent adverse events (TEAEs) 6. Percentage of participants experiencing TEAEs	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 29, 2026