Allergic Rhinitis
Conditions
Brief summary
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Interventions
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject must be 12 years of age or older, of either sex, and of any race. * A subject must have at least a 2-year history of SAR which exacerbates during the study season. * A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1. * A subject must be clinically symptomatic at the Screening and Baseline Visits.
Exclusion criteria
* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing. * 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 prior to the Screening Visit. * A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit. * A subject who is participating in any other clinical study. * A subject who is part of the staff personnel directly involved with this study. * A subject who is a family member (parent, spouse, or sibling) of the investigational study staff. * A female subject who is breast-feeding, pregnant, or intends to become pregnant. * A subject previously randomized into this study. * A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | 15 days of treatment | Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | 15 days of treatment | Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray Mometasone furoate nasal spray 200 mcg QD (once per day) | 168 |
| Placebo Nasal Spray Matching placebo nasal spray | 165 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Treatment Failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 148 Participants | 146 Participants | 294 Participants |
| Sex: Female, Male Female | 109 Participants | 103 Participants | 212 Participants |
| Sex: Female, Male Male | 59 Participants | 62 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 168 | 0 / 165 |
| serious Total, serious adverse events | 0 / 168 | 0 / 165 |
Outcome results
Primary
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Time frame: 15 days of treatment
Population: 1 participant without baseline value excluded from the Placebo Nasal Spray population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | -0.71 Units on a scale | 95% Confidence Interval 0.55 |
| Placebo Nasal Spray | Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | -0.40 Units on a scale | 95% Confidence Interval 0.55 |
Comparison: The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.p-value: <0.00195% CI: [-0.43, -0.19]ANCOVA
Secondary
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Time frame: 15 days of treatment
Population: 1 participant without baseline value excluded from the Placebo Nasal Spray population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | -3.00 Units on a scale | 95% Confidence Interval 2.03 |
| Placebo Nasal Spray | Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | -1.73 Units on a scale | 95% Confidence Interval 2.03 |
Comparison: The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.p-value: <0.00195% CI: [-1.72, -0.83]ANCOVA