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Completed

NCT Number: NCT00999466

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

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Key information

Conditions

Allergic Asthma

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8848

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Pre-treatment (Baseline measurement)

    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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Pre-treatment (Baseline measurement)

    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.

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

    Time frame: 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.

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

    Time frame: 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. PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge

    Time frame: Pre-treatment, pre allergen challenge

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

  5. PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

  54. 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

  55. 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

  56. 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

  57. 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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

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

    Time frame: Pre-treatment, pre allergen challenge

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

    Time frame: Pre-treatment, post allergen challenge

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2009
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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