A Phase 1/2 interventional study of B244 suspension and Vehicle in Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen and Healthy Volunteers, sponsored by AOBiome LLC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by AOBiome LLC · Phase 1/2, Interventional, and Treatment
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal allergic rhinitis.
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal allergic rhinitis. This will be a 2-part study. In Part 1, safety and tolerability will be evaluated during 14 days of study treatment twice-a-day followed by 4 weeks of follow-up in healthy volunteers. In Part 2, preliminary efficacy will be evaluated in subjects with a history of seasonal allergic rhinitis outside of the local pollen season.
For Part 1 (safety and tolerability evaluation in healthy volunteers) we will enroll 24 subjects. Safety and tolerability will be assessed by reporting of AEs, physical examination and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment and up to 28 days of follow-up.
An internal safety committee meeting will review the 2 week Part 1 safety data and, if there are no safety concerns, the study will proceed to Part 2 to evaluate preliminary efficacy in subjects with a history of seasonal allergic rhinitis (SAR)
For Part 2 (preliminary efficacy evaluation in subjects with a history of SAR to ragweed pollen) will enroll 42 subjects. Safety and tolerability will be assessed in subjects with allergic rhinitis by reporting of AEs, physical examination and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment.
For Part 2, study will be paused for safety review using the same stopping criteria as in Part 1.
Rescue medications will not be allowed during the study.
Exclusion Criteria:
Intranasal application: 1 pump (140ul) per nostril BID for 14 days
Biological: Vehicle
Intranasal application: 1 pump (140ul) per nostril BID for 14 days
Biological: B244 suspension
Intranasal application: 1 pump (140ul) per nostril BID for 14 days
Biological: B244 suspension
B244 suspension in 30ml/bottle
Vehicle, 30ml/bottle
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.
Time frame: Baseline to Day 28
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
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.
Time frame: 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.
| Milestone | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Started | 15 | 16 | 16 |
| Completed | 15 | 16 | 16 |
| Not completed | 0 | 0 | 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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Drug Related TEAE | 0 | 0 | 0 |
| Drug Related Severe TEAE | 0 | 0 | 0 |
| Drug Related Serious TEAE | 0 | 0 | 0 |
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.
| score on a scale*hours | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Observed AUC (0-2 Hours) | -5.1 ± 3.53 | -2.5 ± 4.51 | -4.9 ± 3.66 |
| Pre-NAC Adjusted (0-2 Hours) | -5.9 ± 3.88 | -3.7 ± 6.84 | -4.9 ± 3.29 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 2 (Day 0) — None | 4 | 2 | 5 |
| Visit 2 (Day 0) — Mild | 8 | 6 | 4 |
| Visit 2 (Day 0) — Moderate | 0 | 5 | 4 |
| Visit 2 (Day 0) — Severe | 3 | 3 | 3 |
| Visit 3 (Day 14) — None | 3 | 4 | 4 |
| Visit 3 (Day 14) — Mild | 4 | 3 | 4 |
| Visit 3 (Day 14) — Moderate | 6 | 5 | 5 |
| Visit 3 (Day 14) — Severe | 2 | 4 | 3 |
| Visit 4 (Day 28) — None | 3 | 4 | 7 |
| Visit 4 (Day 28) — Mild | 8 | 6 | 6 |
| Visit 4 (Day 28) — Moderate | 3 | 3 | 3 |
| Visit 4 (Day 28) — Severe | 1 | 3 | 0 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 2 (Day 0) — None | 8 | 9 | 8 |
| Visit 2 (Day 0) — Mild | 2 | 5 | 4 |
| Visit 2 (Day 0) — Moderate | 3 | 0 | 3 |
| Visit 2 (Day 0) — Severe | 2 | 2 | 1 |
| Visit 3 (Day 14) — None | 5 | 6 | 6 |
| Visit 3 (Day 14) — Mild | 6 | 5 | 5 |
| Visit 3 (Day 14) — Moderate | 3 | 1 | 3 |
| Visit 3 (Day 14) — Severe | 1 | 4 | 2 |
| Visit 4 (Day 28) — None | 11 | 10 | 10 |
| Visit 4 (Day 28) — Mild | 2 | 3 | 4 |
| Visit 4 (Day 28) — Moderate | 2 | 1 | 2 |
| Visit 4 (Day 28) — Severe | 0 | 2 | 0 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 2 (Day 0) — None | 6 | 10 | 10 |
| Visit 2 (Day 0) — Mild | 4 | 4 | 2 |
| Visit 2 (Day 0) — Moderate | 2 | 1 | 3 |
| Visit 2 (Day 0) — Severe | 3 | 1 | 1 |
| Visit 3 (Day 14) — None | 6 | 7 | 9 |
| Visit 3 (Day 14) — Mild | 4 | 5 | 4 |
| Visit 3 (Day 14) — Moderate | 5 | 3 | 2 |
| Visit 3 (Day 14) — Severe | 0 | 1 | 1 |
| Visit 4 (Day 28) — None | 11 | 11 | 13 |
| Visit 4 (Day 28) — Mild | 4 | 3 | 3 |
| Visit 4 (Day 28) — Moderate | 0 | 1 | 0 |
| Visit 4 (Day 28) — Severe | 0 | 1 | 0 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 2 (Day 0) — None | 9 | 13 | 11 |
| Visit 2 (Day 0) — Mild | 5 | 3 | 3 |
| Visit 2 (Day 0) — Moderate | 1 | 0 | 2 |
| Visit 2 (Day 0) — Severe | 0 | 0 | 0 |
| Visit 3 (Day 14) — None | 9 | 13 | 13 |
| Visit 3 (Day 14) — Mild | 5 | 1 | 1 |
| Visit 3 (Day 14) — Moderate | 1 | 2 | 1 |
| Visit 3 (Day 14) — Severe | 0 | 0 | 1 |
| Visit 4 (Day 28) — None | 10 | 13 | 13 |
| Visit 4 (Day 28) — Mild | 5 | 3 | 3 |
| Visit 4 (Day 28) — Moderate | 0 | 0 | 0 |
| Visit 4 (Day 28) — Severe | 0 | 0 | 0 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Yes | 3 | 4 | 7 |
| No | 12 | 12 | 9 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Yes | 11 | 10 | 10 |
| No | 4 | 6 | 6 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Yes | 11 | 11 | 13 |
| No | 4 | 5 | 3 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Yes | 10 | 13 | 13 |
| No | 5 | 3 | 3 |
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.
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| 25% Reduction from Visit 2 Observed AUC (0-120 minutes) — Yes | 9 | 6 | 12 |
| 25% Reduction from Visit 2 Observed AUC (0-120 minutes) — No | 6 | 10 | 4 |
| 25% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) — Yes | 9 | 8 | 15 |
| 25% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) — No | 6 | 8 | 1 |
| 50% Reduction from Visit 2 Observed AUC (0-120 minutes) — Yes | 3 | 3 | 6 |
| 50% Reduction from Visit 2 Observed AUC (0-120 minutes) — No | 12 | 13 | 10 |
| 50% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) — Yes | 7 | 6 | 8 |
| 50% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) — No | 8 | 10 | 8 |
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.
| L*Hr/min | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Change from Visit 3 to Visit 4 | -60.8 ± 57.83 | -8.6 ± 39.62 | -60.9 ± 57.48 |
| Change from Visit 2 to Visit 4 | -51.2 ± 99.99 | -30.4 ± 96.76 | -59.8 ± 57.77 |
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).
| Participants | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 3 (Day 14) — None | 0 | 0 | 0 |
| Visit 3 (Day 14) — Mild | 5 | 4 | 8 |
| Visit 3 (Day 14) — Moderate | 8 | 10 | 8 |
| Visit 3 (Day 14) — Severe | 2 | 2 | 0 |
| Visit 4 (Day 28) — None | 2 | 2 | 6 |
| Visit 4 (Day 28) — Mild | 9 | 9 | 5 |
| Visit 4 (Day 28) — Moderate | 3 | 4 | 5 |
| Visit 4 (Day 28) — Severe | 1 | 1 | 0 |
Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).
| ppb | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) |
|---|---|---|---|
| Visit 3 (Day 14) | 61.9 ± 57.77 | 33.9 ± 26.68 | 81.9 ± 104.88 |
| Visit 4 (Day 28) | 63.6 ± 55.42 | 27.3 ± 25.25 | 52.7 ± 41.13 |
To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.
No measurements were reported for this outcome.
Collected over Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Vehicle | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Part 1: B244 1x (Low Dose) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Part 1: B244 4x (Mid Dose) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Part 2: Vehicle | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Part 2: B244 1x (Low Dose) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Part 2: B244 4x (Mid Dose) | 0/16 (0%) | 0/16 (0%) | 4/16 (25%) |
| Event | Part 1: Vehicle | Part 1: B244 1x (Low Dose) | Part 1: B244 4x (Mid Dose) | Part 2: Vehicle | Part 2: B244 1x (Low Dose) | Part 2: B244 4x (Mid Dose) |
|---|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 0/8 | 1/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 0/8 | 0/8 | 1/8 | 0/15 | 0/16 | 0/16 |
| Nasal drynessRespiratory, thoracic and mediastinal disorders | 1/8 | 0/8 | 0/8 | 0/15 | 0/16 | 0/16 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 0/8 | 0/8 | 0/8 | 1/15 | 0/16 | 0/16 |
| Ear congestionEar and labyrinth disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| Chest discomfortGeneral disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| HeadacheNervous system disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| WheezingRespiratory, thoracic and mediastinal disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
| Pain of skinSkin and subcutaneous tissue disorders | 0/8 | 0/8 | 0/8 | 0/15 | 0/16 | 1/16 |
Population includes patients from Part 1 (n=24) Part 2 (n=47) of the study.
| Age, Continuous(years) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 | 47.29 ± 11.179 | 44.60 ± 11.193 | 45.36 ± 10.316 | 45.76 ± 10.477 |
| Part 2 | 47.20 ± 9.470 | 45.49 ± 12.145 | 42.30 ± 12.754 | 44.95 ± 11.516 |
| Sex: Female, Male(Participants) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 — Female | 3 | 5 | 3 | 11 |
| Part 1 — Male | 5 | 3 | 5 | 13 |
| Part 2 — Female | 10 | 12 | 9 | 31 |
| Part 2 — Male | 5 | 4 | 7 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 — Hispanic or Latino | 3 | 5 | 5 | 13 |
| Part 1 — Not Hispanic or Latino | 5 | 2 | 1 | 8 |
| Part 1 — Unknown or Not Reported | 0 | 1 | 2 | 3 |
| Part 2 — Hispanic or Latino | 3 | 1 | 3 | 7 |
| Part 2 — Not Hispanic or Latino | 12 | 15 | 13 | 40 |
| Part 2 — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Part 1 — Asian | 0 | 1 | 2 | 3 |
| Part 1 — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Part 1 — Black or African American | 2 | 2 | 1 | 5 |
| Part 1 — White | 6 | 5 | 5 | 16 |
| Part 1 — More than one race | 0 | 0 | 0 | 0 |
| Part 1 — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Part 2 — American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Part 2 — Asian | 3 | 2 | 6 | 11 |
| Part 2 — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Part 2 — Black or African American | 5 | 9 | 5 | 19 |
| Part 2 — White | 6 | 5 | 5 | 16 |
| Part 2 — More than one race | 0 | 0 | 0 | 0 |
| Part 2 — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Tobacco History(Participants) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 — Never | 8 | 8 | 5 | 21 |
| Part 1 — Current | 0 | 0 | 0 | 0 |
| Part 1 — Former | 0 | 0 | 3 | 3 |
| Part 2 — Never | 12 | 16 | 16 | 44 |
| Part 2 — Current | 0 | 0 | 0 | 0 |
| Part 2 — Former | 3 | 0 | 0 | 3 |
| Screening Height(cm) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 | 174.0 ± 8.20 | 169.8 ± 8.40 | 172.8 ± 11.60 | 172.2 ± 9.24 |
| Part 2 | 169.0 ± 3.73 | 165.9 ± 8.38 | 167.1 ± 9.88 | 167.3 ± 8.39 |
| Screening Weight(kg) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 | 81.83 ± 22.316 | 77.94 ± 10.679 | 89.55 ± 21.376 | 83.10 ± 18.699 |
| Part 2 | 76.89 ± 15.279 | 79.69 ± 14.577 | 79.72 ± 17.633 | 78.81 ± 15.604 |
| Screening BMI(kg/m^2) | Vehicle | B 244 1x (Low Dose) | B244 4x (Mid Dose) | Total |
|---|---|---|---|---|
| Part 1 | 26.77 ± 5.890 | 27.15 ± 4.197 | 29.76 ± 5.013 | 27.89 ± 5.046 |
| Part 2 | 26.86 ± 4.803 | 28.93 ± 4.868 | 28.59 ± 6.053 | 28.15 ± 5.250 |
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