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The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD

NCT03794557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-01

No results posted yet for this study

Summary

This is a study examining the effect of inhaled PUL-042 on peak lower respiratory symptoms as measured by subject diary in early stage COPD subjects who are experimentally infected with rhinovirus.

Subjects will receive 1 dose of PUL-042 followed by inoculation with HRV A16 virus 24 hours later. An additional dose of PUL-042 will be administered 48 hours post-inoculation. Subjects will be followed for 6 weeks post-inoculation

Conditions

Interventions

DRUG

Sterile Water Injection

Inhaled Sterile Water Injection

DRUG

PUL-042 Inhalation Solution

PUL-042 Inhalation Solution

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • VirTus Respiratory Research Ltd

    collaborator UNKNOWN

  • MWB Consulting Ltd

    collaborator UNKNOWN

  • Data Magik Ltd

    collaborator UNKNOWN

  • Pulmotect, Inc.

    lead INDUSTRY

Principal Investigators

  • Onn Min Kon, MD · Imperial College Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-21
Primary Completion
2020-12-16
Completion
2021-03-23

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03794557 on ClinicalTrials.gov