Allergic Rhinitis, Allergic Conjunctivitis
Conditions
Brief summary
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.
Interventions
two sprays in each nostril once daily
two sprays in each nostril once daily
Sponsors
ORA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* provide written informed consent and signed HIPAA form; * be able and willing to follow all instructions and attend the study visits; * if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control * have a positive history of seasonal allergic rhinitis to ragweed; * have a positive skin test reaction to ragweed of within the past 24 months; * manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC
Exclusion criteria
* known intolerance or allergy to antihistamines or corticosteroids; * have a compromised lung function at Visit 1; * develop a compromised lung function at Visits 2-6 * have any presence of active sinus or nasal infection at any visit; * have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1; * have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa) * have had any nasal surgical intervention in the past; * have a known history of glaucoma * have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter; * inability or refusal to discontinue contact lens wear during all visits; * use disallowed medications during the study or appropriate pre-study washout period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and 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. |
| Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and 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. |
| Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and 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. |
| Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one site in the US.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Fluticasone Propionate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 1 / 11 | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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.
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Population: All Randomized Participants Population - All participants who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 30 minutes | -4.1 units on a scale | Standard Deviation 3.4 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 105 minutes | -5.0 units on a scale | Standard Deviation 4 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 60 minutes | -4.7 units on a scale | Standard Deviation 3.6 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 120 minutes | -5.9 units on a scale | Standard Deviation 3.1 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 15 minutes | -2.8 units on a scale | Standard Deviation 3.4 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 135 minutes | -4.8 units on a scale | Standard Deviation 4 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 75 minutes | -4.5 units on a scale | Standard Deviation 4.5 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 150 minutes | -5.3 units on a scale | Standard Deviation 3.6 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 45 minutes | -3.9 units on a scale | Standard Deviation 4.2 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 165 minutes | -5.4 units on a scale | Standard Deviation 3.2 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 90 minutes | -4.5 units on a scale | Standard Deviation 4.3 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 180 minutes | -5.9 units on a scale | Standard Deviation 3 |
| Fluticasone Propionate Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | pre-ABC | -0.7 units on a scale | Standard Deviation 1.8 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 180 minutes | -0.6 units on a scale | Standard Deviation 3 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | pre-ABC | 0.3 units on a scale | Standard Deviation 1.8 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 15 minutes | 0.9 units on a scale | Standard Deviation 3.8 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 30 minutes | -0.6 units on a scale | Standard Deviation 3 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 45 minutes | -0.3 units on a scale | Standard Deviation 3.1 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 60 minutes | -0.9 units on a scale | Standard Deviation 3.3 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 75 minutes | -2.3 units on a scale | Standard Deviation 3.7 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 90 minutes | -1.7 units on a scale | Standard Deviation 3.3 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 105 minutes | -1.6 units on a scale | Standard Deviation 2.5 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 120 minutes | -0.7 units on a scale | Standard Deviation 3.5 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 135 minutes | -0.5 units on a scale | Standard Deviation 3.2 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 150 minutes | -1.7 units on a scale | Standard Deviation 2.6 |
| Placebo Nasal Spray | Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) | 165 minutes | -1.6 units on a scale | Standard Deviation 2.8 |
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.
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 30 minutes | -0.7 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 105 minutes | -1.2 units on a scale | Standard Deviation 1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 60 minutes | -1 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 120 minutes | -1.5 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 15 minutes | -0.4 units on a scale | Standard Deviation 1.2 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 135 minutes | -1.1 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 75 minutes | -0.9 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 150 minutes | -1.4 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 45 minutes | -1.1 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 165 minutes | -1.4 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 90 minutes | -1.1 units on a scale | Standard Deviation 1.2 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 180 minutes | -1.5 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | Pre-ABC | -0.1 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 180 minutes | -0.1 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | Pre-ABC | 0 units on a scale | Standard Deviation 0.7 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 15 minutes | 0.1 units on a scale | Standard Deviation 1.3 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 30 minutes | -0.1 units on a scale | Standard Deviation 1.2 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 45 minutes | 0 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 60 minutes | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 75 minutes | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 90 minutes | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 105 minutes | -0.2 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 120 minutes | -0.2 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 135 minutes | -0.2 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 150 minutes | -0.3 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16 | 165 minutes | -0.3 units on a scale | Standard Deviation 0.8 |
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.
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 30 minutes | -1 units on a scale | Standard Deviation 1.2 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 105 minutes | -1.3 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 60 minutes | -1.3 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 120 minutes | -1.5 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 15 minutes | -1 units on a scale | Standard Deviation 1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 135 minutes | -1.5 units on a scale | Standard Deviation 1.2 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 75 minutes | -1.3 units on a scale | Standard Deviation 1.5 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 150 minutes | -1.5 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 45 minutes | -0.8 units on a scale | Standard Deviation 1.6 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 165 minutes | -1.5 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 90 minutes | -1 units on a scale | Standard Deviation 1.6 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 180 minutes | -1.8 units on a scale | Standard Deviation 1.2 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | Pre-ABC | -0.2 units on a scale | Standard Deviation 0.6 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 180 minutes | 0 units on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | Pre-ABC | 0.1 units on a scale | Standard Deviation 0.7 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 15 minutes | 0.3 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 30 minutes | -0.1 units on a scale | Standard Deviation 0.6 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 45 minutes | -0.1 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 60 minutes | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 75 minutes | -0.5 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 90 minutes | -0.6 units on a scale | Standard Deviation 0.7 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 105 minutes | -0.5 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 120 minutes | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 135 minutes | -0.3 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 150 minutes | -0.2 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16 | 165 minutes | -0.2 units on a scale | Standard Deviation 1 |
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.
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 30 minutes | -1.5 units on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 105 minutes | -1.4 units on a scale | Standard Deviation 1.4 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 60 minutes | -1.2 units on a scale | Standard Deviation 1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 120 minutes | -1.7 units on a scale | Standard Deviation 0.6 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 15 minutes | -0.9 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 135 minutes | -1.4 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 75 minutes | -1.3 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 150 minutes | -1.5 units on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 45 minutes | -1.1 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 165 minutes | -1.4 units on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 90 minutes | -1.5 units on a scale | Standard Deviation 1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 180 minutes | -1.5 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | Pre-ABC | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 180 minutes | -0.3 units on a scale | Standard Deviation 1.2 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | Pre-ABC | 0 units on a scale | Standard Deviation 0.5 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 15 minutes | 0.4 units on a scale | Standard Deviation 1.2 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 30 minutes | 0 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 45 minutes | -0.2 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 60 minutes | -0.1 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 75 minutes | -0.7 units on a scale | Standard Deviation 1.3 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 90 minutes | -0.5 units on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 105 minutes | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 120 minutes | -0.1 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 135 minutes | 0 units on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 150 minutes | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16 | 165 minutes | -0.4 units on a scale | Standard Deviation 0.8 |
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.
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 30 minutes | -0.9 units on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 105 minutes | -1.2 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 60 minutes | -1.3 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 120 minutes | -1.3 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 15 minutes | -0.5 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 135 minutes | -0.9 units on a scale | Standard Deviation 1.4 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 75 minutes | -1.1 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 150 minutes | -0.8 units on a scale | Standard Deviation 1.3 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 45 minutes | -0.9 units on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 165 minutes | -1.1 units on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 90 minutes | -1.1 units on a scale | Standard Deviation 1.4 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 180 minutes | -1.2 units on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | Pre-ABC | -0.1 units on a scale | Standard Deviation 0.3 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 180 minutes | -0.1 units on a scale | Standard Deviation 0.7 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | Pre-ABC | 0.2 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 15 minutes | 0.1 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 30 minutes | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 45 minutes | 0 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 60 minutes | -0.2 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 75 minutes | -0.6 units on a scale | Standard Deviation 1.3 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 90 minutes | -0.3 units on a scale | Standard Deviation 1.2 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 105 minutes | -0.4 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 120 minutes | -0.1 units on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 135 minutes | 0 units on a scale | Standard Deviation 0.9 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 150 minutes | -0.7 units on a scale | Standard Deviation 1 |
| Placebo Nasal Spray | Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16 | 165 minutes | -0.6 units on a scale | Standard Deviation 1 |