Phase 2
Completed N=9
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
Source: ClinicalTrials.gov NCT00999466 ↗Enrolled (actual)
9
Serious AEs
—
Results posted
Jan 2016
Primary outcomePrimary: FEV1, Late Asthmatic Response (LAR) - Pre-treatment — 0.814; 1.01 ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1, Late Asthmatic Response (LAR) - Pre-treatment |
0.814; 1.01 | — |
| PRIMARY FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose |
0.616; 0.970 | — |
| PRIMARY FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose |
0.759; 0.722 | — |
| SECONDARY FEV1, Early Asthmatic Response (EAR) - Pre-treatment |
0.524; 0.611 | — |
| SECONDARY FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose |
0.468; 0.624 | — |
| SECONDARY FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose |
0.510; 0.591 | — |
| SECONDARY PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge |
0.564; 0.609 | — |
| SECONDARY PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge |
0.425; 0.364 | — |
| SECONDARY PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge |
0.488; 0.454 | — |
| SECONDARY PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge |
0.691; 0.340 | — |
| SECONDARY PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.468; 0.504 | — |
| SECONDARY PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge |
0.326; 0.508 | — |
| SECONDARY Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge |
8.9; 4.8 | — |
| SECONDARY Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge |
13; 12 | — |
| SECONDARY Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge |
6.5; 5.3 | — |
| SECONDARY Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge |
11; 8.4 | — |
| SECONDARY Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge |
5.1; 9.4 | — |
| SECONDARY Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge |
13; 7.9 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge |
37; 23 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge |
41; 44 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge |
37; 36 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge |
45; 37 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge |
29; 43 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge |
72; 41 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge |
0.83; 0.87 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge |
7.1; 5.8 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge |
0.82; 1.3 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge |
7.8; 5.4 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge |
1.2; 1.7 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge |
5.7; 8.0 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge |
15; 9.4 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge |
28; 27 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge |
15; 9.6 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge |
26; 23 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge |
12; 21 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge |
20; 29 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge |
766; 522 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge |
1300; 1450 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge |
720; 609 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge |
1272; 1270 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge |
496; 1012 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge |
1500; 1304 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge |
0.57; 0.63 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge |
0.86; 0.68 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge |
0.60; 0.75 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge |
0.79; 0.82 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.54; 0.95 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge |
0.68; 0.67 | — |
| SECONDARY Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge |
1.3; 1.4 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge |
3.0; 3.1 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge |
1.3; 1.8 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge |
3.0; 2.8 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge |
1.3; 1.6 | — |
| SECONDARY Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge |
2.5; 3.1 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge |
2.7; 2.7 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge |
5.0; 3.5 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge |
3.7; 3.0 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge |
5.0; 4.2 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge |
1.9; 2.6 | — |
| SECONDARY Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge |
5.2; 4.0 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge |
0.13; 0.12 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge |
0.64; 0.81 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge |
0.18; 0.23 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge |
0.94; 0.82 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.13; 0.21 | — |
| SECONDARY Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge |
1.0; 0.96 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge |
0.75; 0.93 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge |
1.9; 1.5 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge |
1.5; 0.91 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge |
2.1; 1.7 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.80; 1.3 | — |
| SECONDARY Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge |
2.6; 1.6 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge |
1.1; 0.59 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge |
1.1; 0.60 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge |
0.80; 0.36 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge |
1.0; 0.77 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.47; 0.58 | — |
| SECONDARY Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge |
0.56; 0.74 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge |
0.004; 0.004 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge |
0.008; 0.004 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge |
0.002; 0.003 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge |
0.003; 0.003 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.005; 0.005 | — |
| SECONDARY Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge |
0.005; 0.003 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge |
0.045; 0.053 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge |
0.078; 0.073 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge |
0.11; 0.045 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge |
0.067; 0.071 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge |
0.045; 0.054 | — |
| SECONDARY Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge |
0.037; 0.082 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00999466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.