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| Name | Class |
|---|---|
| Johnson & Johnson Consumer and Personal Products Worldwide | INDUSTRY |
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The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4 to 6 weeks, and each of three study visits during that time will last a few hours. Subjects will be required to have several tests done including allergy and breathing tests. They will be exposed to the item they are allergic to and will have small paper discs put in their noses. Subjects will also have the inside of their noses examined and will be asked questions about the level of their allergy symptoms.
This study is a randomized, double blind, placebo-controlled, 2-way cross over trial. Approximately 25 subjects with a history of seasonal grass and/or ragweed allergy symptoms will be enrolled in the study to ensure 20 complete the study.
Subjects will be randomized to one of two treatment sequences of experimental product (investigational nasal spray) and placebo (sham nasal spray). Subjects will be asymptomatic of nasal symptoms (i.e., sneezing, itchy nose, runny nose, and nasal congestion) for at least 2 weeks prior to screening, and at least 1 week after the latest use of concomitant medication for symptom control in order to be eligible to participate in this study. Any subject with a history of mild asthma will be required to undergo a Forced Expiratory Volume in 1 second (FEV1) test prior to each nasal challenge (diluent and allergen) throughout the study. Assessments will be completed pre- and post-diluent challenge and post-allergen challenge. The baseline assessment for symptom scores is defined as the assessment obtained after the diluent challenge but prior (-15 minutes prior to randomization) to the administration of the experimental product/sham control.
Using a 14-day wash out period (± 2days), subjects who continue to meet inclusion criteria will receive treatments according to their randomized sequence. Eligible allergic subjects will undergo nasal challenges with either grass or ragweed allergen outside their allergy season.
Severity of symptoms will be assessed by the subject on a scale of 0=no symptoms to 3=severe. Adverse events will be collected during each visit, as well as the day following each visit via telephone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-1266-7 | Experimental | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo). |
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| Placebo | Experimental | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-1266-7 | Device | Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | 15 minutes (±5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Qi, MD, PhD | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | C-1266-7 Then Placebo | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo). C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment. |
| FG001 | Placebo Then C-1266-7 | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7. C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Single Dose) |
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| Washout Period of 14 to 30 Days |
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| Period 2 (Single Dose) |
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| ID | Title | Description |
|---|---|---|
| BG000 | C-1266-7 | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo). C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | 15 minutes (±5 minutes) |
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Up to 63 days (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who used at least one dose of investigational product/placebo.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C-1266-7 | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6. C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Qi, MD, PhD, Director, Clinical Research | Johnson & Johnson Consumer and Personal Products Worldwide | 973 385-2260 | dqi6@its.jnj.com |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| C-1266-6 (placebo) | Device | Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment. |
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| 1 hour |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | 15 minutes |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | Within 1 hour |
| Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge | Change from baseline in number of sneezes | Within 15 minutes |
| Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge | Change from baseline in number of sneezes | Within 1 hour |
| Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge | Change from baseline in number of sneezes | Within 15 minutes |
| Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge | Change from baseline in number of sneezes | Within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 15 minutes |
| Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 1 hour |
| Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 15 minutes |
| Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 1 hour |
| Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 15 minutes |
| Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | within 1 hour |
| Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | within 15 minutes |
| Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | within 1 hour |
| Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | within 15 minutes |
| Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | within 1 hour |
| Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 15 minutes |
| Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 1 hour |
| Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 15 minutes |
| Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | within 1 hour |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Placebo | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7. C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.
| OG001 | Placebo | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7. C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment. |
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| Secondary | Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | 1 hour |
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| Secondary | Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
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| Secondary | Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge | The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | Within 1 hour |
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| Secondary | Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge | Change from baseline in number of sneezes | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | sneezes | Within 15 minutes |
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| Secondary | Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge | Change from baseline in number of sneezes | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | sneezes | Within 1 hour |
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| Secondary | Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge | Change from baseline in number of sneezes | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | sneezes | Within 15 minutes |
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| Secondary | Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge | Change from baseline in number of sneezes | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | sneezes | Within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge | Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | within 1 hour |
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| Secondary | Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| Secondary | Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge | Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge | Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| Secondary | Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | Posted | Number | participants | within 15 minutes |
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| Secondary | Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Number | participants | within 1 hour |
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| Secondary | Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Number | participants | within 15 minutes |
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| Secondary | Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge | A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS. | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Number | participants | within 1 hour |
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| Secondary | Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| Secondary | Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 15 minutes |
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| Secondary | Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge | TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst). | Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects. | Posted | Mean | Standard Error | units on a scale | within 1 hour |
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| 1 |
| 21 |
| 1 |
| 21 |
| EG001 | Placebo | In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7. C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment. Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment. | 0 | 20 | 2 | 20 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
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| Pregnancy of Partner | Social circumstances | MedDRA 15.1 | Systematic Assessment |
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Sponsor has the right to publish results without PI approval. PI has right to present and/or publish research results and related background information, but must provide publication to Sponsor in advance with at least 30 days for review. Sponsor confidential information cannot be submitted for publication without Sponsor's written consent. Sponsor cannot require changes or extend the embargo. If requested, the PI will withhold the publication for ≤60 days to allow for patent application.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |