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 |
|---|---|---|
| The 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, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours \[reflective\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 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 \[reflective\]) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray Mometasone furoate nasal spray 200 mcg QD (once per day) | 176 |
| Placebo Nasal Spray Matching placebo nasal spray | 175 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Treatment Failure | 1 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 14 Participants | 25 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants | 156 Participants | 318 Participants |
| Sex: Female, Male Female | 107 Participants | 116 Participants | 223 Participants |
| Sex: Female, Male Male | 69 Participants | 59 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 176 | 0 / 175 |
| serious Total, serious adverse events | 0 / 176 | 0 / 175 |
Outcome results
Primary
The 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, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours \[reflective\])
Time frame: 15 days of treatment
Population: The standard deviation is pooled.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | -0.64 Units on a scale | Standard Deviation 0.52 |
| Placebo Nasal Spray | The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | -0.49 Units on a scale | Standard Deviation 0.52 |
p-value: 0.006ANCOVA
Secondary
The 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 \[reflective\])
Time frame: 15 days of treatment
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | -2.68 Units on a scale | Standard Deviation 2.01 |
| Placebo Nasal Spray | The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | -1.85 Units on a scale | Standard Deviation 2.01 |
p-value: <0.001ANCOVA