Seasonal Allergic Rhinitis
Conditions
Brief summary
This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.
Interventions
MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days.
OTHERPlacebo
Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days
Sponsors
Integrated Therapeutics Group
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be \>=18 years of age and older, of either sex, and of any race. * Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) * At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) * At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) * Must have a 2-year or longer history of SAR occurring during the same season as the current study. * Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit * Must be free of clinically significant disease that would interfere with study evaluations * Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation. * Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit.
Exclusion criteria
* Women who are pregnant, intend to become pregnant during the study, or are nursing * Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow * Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants * Acute respiratory infection within 2 weeks of the Screening Visit * Diagnosis of clinically relevant sleep problems unassociated with allergies * Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints * Snoring associated with an enlarged uvula or other upper airway pathology * Had episodes of snoring associated with gasping or choking * Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling * Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems * Diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting beta-2 adrenoceptor agonists * Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids. * Currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit and who wish to remain on this schedule during the study are eligible for study inclusion; however, they may not receive hyposensitization treatment within 24 hours prior to any study visit * Smokers or ex-smokers who have smoked within the previous 6 months * Concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders. * Any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. * Subjects participating in any other clinical study(ies). * Subjects allergic to or with a sensitivity to the study drug or its excipients. * Subjects who are night-shift workers or do not have a standard asleep at night/awake during the day cycle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Average of the last 7 days of treatment | The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate. |
| Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | 29 days | Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days. | 267 |
| Placebo Nasal Spray. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days. | 134 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 2 | 1 |
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Non-compliance with protocol | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray | Placebo Nasal Spray. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 259 Participants | 132 Participants | 391 Participants |
| Age, Continuous | 36.1 years STANDARD_DEVIATION 12.8 | 35.1 years STANDARD_DEVIATION 11.8 | 35.7 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 170 Participants | 85 Participants | 255 Participants |
| Sex: Female, Male Male | 97 Participants | 49 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 267 | 7 / 134 |
| serious Total, serious adverse events | 1 / 267 | 0 / 134 |
Outcome results
Primary
Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.
Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
Time frame: 29 days
Population: Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Change from baseline in SLP9 score | -26.1 Units on a scale | Standard Error 1.38 |
| Mometasone Furoate Nasal Spray | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Baseline SLP9 Score | 68.6 Units on a scale | Standard Error 0.86 |
| Placebo Nasal Spray. | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Change from baseline in SLP9 score | -25.8 Units on a scale | Standard Error 1.9 |
| Placebo Nasal Spray. | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Baseline SLP9 Score | 69.2 Units on a scale | Standard Error 1.2 |
Primary
Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.
The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
Time frame: Average of the last 7 days of treatment
Population: Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Change from Baseline in TNSS score | -3.77 Units on a scale | Standard Error 0.19 |
| Mometasone Furoate Nasal Spray | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Baseline TNSS score | 9.10 Units on a scale | Standard Error 0.1 |
| Placebo Nasal Spray. | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Change from Baseline in TNSS score | -3.07 Units on a scale | Standard Error 0.26 |
| Placebo Nasal Spray. | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Baseline TNSS score | 9.12 Units on a scale | Standard Error 0.14 |