Seasonal Allergic Rhinitis
Conditions
Brief summary
This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.
Interventions
DRUGmometasone furoate
50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning
DRUGPlacebo
Two sprays in each nostril once daily in the morning
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be 12 years of age or older, of either sex and of any race. * Must have at least a 2-year documented history of SAR which exacerbates during the study season. * Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes. * Must be clinically symptomatic at the Screening Visit. * Must be clinically symptomatic at the Baseline Visit. * Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count \[CBC\], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor. * Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
Exclusion criteria
* A history of anaphylaxis and/or other severe local reaction(s) to skin testing. * A subject with asthma who requires chronic use of inhaled or systemic corticosteroids. * Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. * A subject with rhinitis medicamentosa. * A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays. * A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit. * A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow. * A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline and 15 days | TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline and 15 days | TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline and 15 days | Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Baseline and 15 days | The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. |
| Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline and 15 days | Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg. | 211 |
| Placebo Two sprays in each nostril once daily | 215 |
| Total | 426 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray (MFNS) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 30 Participants | 48 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 188 Participants | 181 Participants | 369 Participants |
| Sex: Female, Male Female | 140 Participants | 130 Participants | 270 Participants |
| Sex: Female, Male Male | 71 Participants | 85 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 211 | 0 / 215 |
| serious Total, serious adverse events | 0 / 211 | 0 / 215 |
Outcome results
Primary
Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
Time frame: Baseline and 15 days
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline TNSS | 9.83 units on a scale | Standard Deviation 1.56 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Change from Baseline in TNSS | -2.36 units on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline TNSS | 9.69 units on a scale | Standard Deviation 1.56 |
| Placebo | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Change from Baseline in TNSS | -1.71 units on a scale | Standard Deviation 2.07 |
p-value: 0.001ANCOVA
Primary
Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.
Time frame: Baseline and 15 days
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline TOSS | 7.07 units on a scale | Standard Deviation 1.54 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Change from Baseline in TOSS | -1.52 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline TOSS | 7.01 units on a scale | Standard Deviation 1.54 |
| Placebo | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Change from Baseline in TOSS | -1.36 units on a scale | Standard Deviation 1.59 |
p-value: 0.304ANCOVA
Secondary
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.
Time frame: Baseline and 15 days
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline Nasal Congestion Score | 2.66 units on a scale | Standard Deviation 0.4 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Change from Baseline in Nasal Congestion Score | -0.54 units on a scale | Standard Deviation 0.54 |
| Placebo | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline Nasal Congestion Score | 2.64 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Change from Baseline in Nasal Congestion Score | -0.39 units on a scale | Standard Deviation 0.54 |
p-value: 0.004ANCOVA
Secondary
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.
Time frame: Baseline and 15 days
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Change from Baseline in PNIF | 10.15 liters/minute | Standard Deviation 21.1 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline PNIF | 89.11 liters/minute | Standard Deviation 37.2 |
| Placebo | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Change from Baseline in PNIF | 8.24 liters/minute | Standard Deviation 21.1 |
| Placebo | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline PNIF | 88.85 liters/minute | Standard Deviation 37.2 |
p-value: 0.356ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.
Time frame: Baseline and 15 days
Population: The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Baseline RQLQ Total Score | 4.19 units on a scale | Standard Deviation 0.97 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Change from Baseline in RQLQ Total Score | -1.63 units on a scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Baseline RQLQ Total Score | 4.42 units on a scale | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Change from Baseline in RQLQ Total Score | -1.36 units on a scale | Standard Deviation 1.37 |
p-value: 0.063ANCOVA