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A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

NCT03636347 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-04-14

No results posted yet for this study

Summary

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

Conditions

Interventions

DRUG

Placebo Oral Tablet

twice daily administration

DRUG

Alvelestat oral tablet - dose 1

twice daily administration

DRUG

Alvelestat oral tablet - dose 2

twice daily administration

Sponsors & Collaborators

Principal Investigators

  • Robert Stockley, Prof. · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2022-03-02
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03636347 on ClinicalTrials.gov