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Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function

NCT05582798 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-03

No results posted yet for this study

Summary

Double-blind, randomized, cross-over trial involving 20 participants with bronchiectasis.

This trial will make an important contribution to therapeutic development in bronchiectasis by determining whether alpha-1 antitrypsin (AAT) therapy results in reduced airway inflammation and improves neutrophil function.

Patients will be randomly assigned to receive Prolastin-C 120mg/kg (n=10 patients) by weekly intravenous infusions, Prolastin-C 180mg/kg (n=10 patients) by weekly intravenous infusions or placebo (0.9% saline) for a period of 4 weeks, followed by a 3-5 week washout period and a further 4 weeks during which patients will cross-over to receive the alternative therapy.

Conditions

  • Bronchiectasis Adult

Interventions

DRUG

Alpha 1-Proteinase Inhibitor 180mg/kg

alpha1-proteinase inhibitor (human) intravenous infusion

DRUG

Alpha 1-Proteinase Inhibitor 120mg/kg

alpha1-proteinase inhibitor (human) intravenous infusion

DRUG

Sodium chloride

Sodium chloride 09.% intravenous infusion

Sponsors & Collaborators

  • University of Dundee

    lead OTHER

Principal Investigators

  • James Chalmers · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-08-12
Completion
2024-08-12
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582798 on ClinicalTrials.gov