| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study. | Population included subjects from Part 1 of the study and those who had received at least one dose of study medication. | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
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| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
| | | Title | Denominators | Categories |
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| Drug Related TEAE | | | | Drug Related Severe TEAE | |
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| Secondary | Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment | Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value. | Population includes only patients from Part 2 of the study. | Posted | | Mean | Standard Deviation | score on a scale*hours | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
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| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) |
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| Secondary | Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
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| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
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| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml)in 30ml/bottle |
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| Secondary | Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Secondary | Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment | Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value. | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | |
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| Other Pre-specified | Change in Peak Nasal Inspiratory Flow (PNIF) | Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. | Population includes only patients from Part 2 of the study. | Posted | | Mean | Standard Deviation | L*Hr/min | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | |
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| Other Pre-specified | Nasal Inflammation Score Using Otoscope | Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC). | Population includes only patients from Part 2 of the study. | Posted | | Count of Participants | | Participants | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Other Pre-specified | Intranasal Nitric Oxide Levels | Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC). | Population includes only patients from Part 2 of the study. | Posted | | Mean | Standard Deviation | ppb | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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| Other Pre-specified | Change in Cytokine Concentration in Nasal Cavity and Blood | To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood. | Data was not collected for this exploratory endpoint. | Posted | | | | | | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | | | | ID | Title | Description |
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| OG000 | Vehicle | Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle | | OG001 | B 244 1x (Low Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle | | OG002 | B244 4x (Mid Dose) | Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle |
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