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

Allergic Asthma Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999466
• Other study ID #: D0540C00004
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2009
• Last updated: January 28, 2016
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• AZD8848
Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
• Placebo
Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

Locations

Country	Name	City	State
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment (Baseline measurement)	No
Primary	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.	1 week after last dose	No
Primary	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.	4 weeks after last dose	No
Secondary	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.	Pre-treatment (Baseline measurement)	No
Secondary	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.	1 week after last dose	No
Secondary	FEV1, Early Asthmatic Response (EAR) - 4 Weeks 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.	4 weeks after last dose	No
Secondary	PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	Pre-treatment, pre allergen challenge	No
Secondary	PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	Pre-treatment, post allergen challenge	No
Secondary	PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	1 week after last dose, pre allergen challenge	No
Secondary	PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	1 week after last dose, post allergen challenge	No
Secondary	PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	4 weeks after last dose, pre allergen challenge	No
Secondary	PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge	PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1	4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFa) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, TNFa - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, TNFa - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, TNFa - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, TNFa - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, TNFa - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-1ß (IL-1ß) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-1ß - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-1ß - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-1ß - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-1ß - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-1ß - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge		Pre-treatment, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge		Pre-treatment, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge		1 week after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge		1 week after last dose, post allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge		4 weeks after last dose, pre allergen challenge	No
Secondary	Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge		4 weeks after last dose, post allergen challenge	No

External Links

•   CSR Synopsis