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A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen

NCT04187508 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-11-03

No results posted yet for this study

Summary

This is a Phase IIa, double blind, randomized, parallel group, placebo controlled multi centre study to evaluate the effect of AZD8154 (administered via nebulizer daily \[QD\]) on allergen-induced inflammation in subjects with mild allergic asthma challenged with an inhaled allergen. Approximately 36 subjects who meet all eligibility criteria will be randomized (1:1) to receive either AZD8154 or placebo.

Conditions

Interventions

DRUG

AZD8154 nebulizer suspension, 20 mg/mL

Subjects will receive AZD8154 from Day 1 to Day 10 (10 consecutive days) by using nebulizer and dosimeter system as inhaled dosing and delivered dose will be 3mg.

DRUG

Placebo

Subjects will receive AZD8154 matching placebo (placebo nebulizer suspension, glucose solution for infusion 50 mg/mL) QD from Day 1 to Day 10 (10 consecutive days) by using nebulizer and dosimeter system as inhaled dosing.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2021-11-10
Completion
2021-11-10

Countries

  • Canada

Study Locations

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Entities

Drugs
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 NCT04187508 on ClinicalTrials.gov