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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999466
First received: October 20, 2009
Last updated: January 28, 2016
Last verified: January 2016

October 20, 2009
January 28, 2016
October 2009
February 2011   (final data collection date for primary outcome measure)
  • FEV1, Late Asthmatic Response (LAR) - Pre-treatment [ Time Frame: Pre-treatment (Baseline measurement) ] [ Designated as safety issue: No ]
    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.
  • FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose [ Time Frame: 1 week after last dose ] [ Designated as safety issue: No ]
    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.
  • FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose [ Time Frame: 4 weeks after last dose ] [ Designated as safety issue: No ]
    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.
FEV1, Late Asthmatic Response (LAR) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00999466 on ClinicalTrials.gov Archive Site
  • FEV1, Early Asthmatic Response (EAR) - Pre-treatment [ Time Frame: Pre-treatment (Baseline measurement) ] [ Designated as safety issue: No ]
    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.
  • FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose [ Time Frame: 1 week after last dose ] [ Designated as safety issue: No ]
    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.
  • FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose [ Time Frame: 4 weeks after last dose ] [ Designated as safety issue: No ]
    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.
  • PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
    PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
  • Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge [ Time Frame: Pre-treatment, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge [ Time Frame: Pre-treatment, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge [ Time Frame: 1 week after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge [ Time Frame: 1 week after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge [ Time Frame: 4 weeks after last dose, pre allergen challenge ] [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge [ Time Frame: 4 weeks after last dose, post allergen challenge ] [ Designated as safety issue: No ]
  • FEV1, Early Asthmatic Response (EAR) [ Designated as safety issue: No ]
  • PC20 Methacholine Challenge - Bronchial Hyperreactivity measured by FEV1 [ Designated as safety issue: No ]
  • Sputum Cellularity and Cytokines - Sputum Biomarkers. [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Asthma
  • Drug: AZD8848
    Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
  • Drug: Placebo
    Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.
  • Experimental: 1
    AZD8848 (30 μg PILOT part and 60 μg MAIN part)
    Intervention: Drug: AZD8848
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00999466
D0540C00004
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Leif Eriksson, MD AstraZeneca R&D Lund
Principal Investigator: Brian Leaker, MD Respiratory Clinical Trials
AstraZeneca
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP