The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

AstraZeneca60 enrolled

Overview

AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Asthma

Interventions

AZD8848DRUG

Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.

PlaceboDRUG

Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * FEV1 \> 70 % of predicted normal pre-bronchodilator * Documented history of asthma * Presence of allergic sensitivity Exclusion Criteria: * Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. * Symptomatic allergic rhinitis * Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study

Locations (2)

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

FEV1, Late Asthmatic Response (LAR) - Pre-treatment

Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: Pre-treatment (Baseline measurement)

FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose

FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: 1 week after last dose

FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose

FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: 4 weeks after last dose

Secondary Outcomes

FEV1, Early Asthmatic Response (EAR) - Pre-treatment

FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: Pre-treatment (Baseline measurement)

FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose

FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: 1 week after last dose

FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

Time frame: 4 weeks after last dose

PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: Pre-treatment, pre allergen challenge

PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: Pre-treatment, post allergen challenge

PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: 1 week after last dose, pre allergen challenge

PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: 1 week after last dose, post allergen challenge

PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: 4 weeks after last dose, pre allergen challenge

PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge

PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge

Time frame: Pre-treatment, pre allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge

Time frame: Pre-treatment, post allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge

Time frame: 1 week after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge

Time frame: 1 week after last dose, post allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge

Time frame: 4 weeks after last dose, pre allergen challenge

Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge

Time frame: 4 weeks after last dose, post allergen challenge