Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8848 · 8 trials · 8 indications
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
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), 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), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Summary of number of subjects who had at least one adverse event
| Arm | Type | Description |
|---|---|---|
| 1. AZD8848 | EXPERIMENTAL | 20 μg AZD8848 three times weekly |
| 2. Placebo | PLACEBO_COMPARATOR | Placebo three times weekly |
| 3. AZD8848 and placebo | EXPERIMENTAL | 60 μg AZD8848 once weekly and placebo twice weekly |
| 1 | EXPERIMENTAL | AZD8848 (30 μg PILOT part and 60 μg MAIN part) |
| 2 | PLACEBO_COMPARATOR | Placebo |
| AZD8848 | EXPERIMENTAL | Subjects will participate in 1 of 3 groups and receive multiple doses of AZD8848 or matching placebo In each group 6 subjects will receive AZD8848 and 2 subjects will receive matching placebo. |
| Placebo to match AZD8848 | PLACEBO_COMPARATOR | Subjects will participate in 1 of 3 groups and receive multiple doses of AZD8848 or matching placebo. In each group 6 subjects will receive AZD8848 and 2 subjects will receive matching placebo. |
| Placebo | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6. |
| 4 | EXPERIMENTAL | Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6. |
| 5 | EXPERIMENTAL | Active treatment once daily on 7 days |
| Name | Type | Description |
|---|---|---|
| AZD8848 | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
| Placebo | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
| AZD8848 and placebo | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
| Placebo to match AZD8848 | DRUG | Multiple doses inhaled matching placebo via a nebulizer |
Inclusion Criteria: * Seasonal allergic rhinitis patients out of pollen season * Have a history and presence of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) * Patients with need of treatment for their...
AZD8848 is an investigational small molecule being studied for respiratory conditions, including allergic rhinitis and allergic asthma. It has also been evaluated in healthy volunteers and in subjects with butyrylcholinesterase deficiency. The drug is administered intranasally and is currently in clinical development, with studies completed through Phase 2.
AZD8848 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety, tolerability, and effects of AZD8848 in various populations, including those with allergic rhinitis and allergic asthma.
AZD8848 has completed clinical trials in Phase 1 and Phase 2. The Phase 2 trial investigated its tolerability and effects in allergic asthma subjects challenged with inhaled allergen. All trials listed for AZD8848 are completed, and the drug remains investigational, not yet approved by regulatory authorities.
AZD8848 has been studied in four completed clinical trials. NCT00688779 assessed tolerability and safety in healthy male volunteers and seasonal allergic rhinitis patients. NCT00999466 evaluated tolerability and effects in allergic asthma subjects. NCT01205867 studied safety in butyrylcholinesterase deficient subjects, and NCT01818869 assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects.
AZD8848 is not FDA approved. It is an investigational drug that has completed clinical trials, including a Phase 2 study in allergic asthma. The drug remains in clinical development, and its safety and efficacy have not been established for any indication. Approval status is not indicated in the available trial information.