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The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Nasal Spray | Placebo Comparator | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
|
| Fluticasone Propionate | Active Comparator | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Drug | two sprays in each nostril once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed. | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal itching score between Day 0 and Day 16 was analyzed. | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Shazly, MD | ORA, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora, Inc. | Andover | Massachusetts | 01810 | United States |
Twenty-two participants enrolled and completed the study. Participant flow and baseline characteristics are presented for the 22 subjects that met all inclusion criteria, none of the exclusion criteria and were randomized to receive Fluticasone Propionate or Placebo nasal spray twice daily based on the randomization list.
Subjects were recruited from one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Propionate Nasal Spray | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
| FG001 | Placebo Nasal Spray | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Propionate Nasal Spray | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
| BG001 | Placebo Nasal Spray | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed. | All Randomized Participants Population - All participants who received study treatment | Posted | Mean | Standard Deviation | units on a scale | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
|
Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
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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 | Fluticasone Propionate Nasal Spray | Two sprays in each nostril daily starting the day after Day 1 for up to 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hives (neck) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Pearson | Ora | 978-685-8900 | cpearson@oraclinical.com |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Saline Nasal Spray | Drug | two sprays in each nostril once daily |
|
| Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average sneezing score between Day 0 and Day 16 was analyzed. | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
| Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average rhinorrhea score between Day 0 and Day 16 was analyzed. | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
| Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal congestion score between Day 0 and Day 16 was analyzed. | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
|
|
| Secondary | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal itching score between Day 0 and Day 16 was analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
|
|
|
| Secondary | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average sneezing score between Day 0 and Day 16 was analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
|
|
|
| Secondary | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average rhinorrhea score between Day 0 and Day 16 was analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
|
|
|
| Secondary | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal congestion score between Day 0 and Day 16 was analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Placebo Nasal Spray | Two sprays in each nostril daily starting the day after Day 1 for up to 14 days. | 0 | 11 | 0 | 11 | 3 | 11 |
| dizziness | General disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| hives (face) | General disorders | Systematic Assessment |
|
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 30 minutes |
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| 45 minutes |
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| 75 minutes |
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| 90 minutes |
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| 105 minutes |
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