Seasonal Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
Interventions
DRUGMometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
OTHERPlacebo
Placebo: 2 sprays in each nostril
Sponsors
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Willing to participate and to adhere to dose and visit schedules * 18 to 65 years, either sex, any race * 2-year history of SAR, being symptomatic during the last 2 ragweed seasons * Skin test positive to short ragweed allergen at screening, or positive within 12 months * Women must practice adequate contraception: Females of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for \>1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.; Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation) * Negative pregnancy tests during study
Exclusion criteria
* Compromised ability to provide informed consent * Nasal abnormalities, including large nasal polyps, and marked septum deviation that interferes with nasal airflow at screening * Recent (within the last 2 weeks) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma * Unstable asthma which cannot be controlled with inhaled short-acting beta-2 agonists * Diagnosed with sinusitis within the previous 2 weeks * Is initiating or is currently on advanced immunotherapy * If on immunotherapy (desensitization therapy), the subject must be stable and should not receive an increase in dose during the study. Subjects may not receive desensitization treatment within 24 hours prior to a study visit * Is currently on or has been on an antihistamine, decongestant (topical or systemic) or a nasal inhaled corticosteroid during the 14 days prior to the first priming visit * Unable to refrain from regular use of nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids * Failed the designated washout periods for any of the prohibited medications * Upper or lower respiratory tract or sinus infection that required antibiotic therapy or a viral upper or lower respiratory infection within 14 days prior to screening * Is allergic to or has sensitivity to the study drug or its excipients * Used any investigational product within 30 days before enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days * Subject has Chronic obstructive pulmonary disease, Alcohol abuse, Rhinitis medicamentosa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | Baseline and 6 hours following initial dosing | Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray Day 1 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose | 77 |
| Placebo Day 1 Placebo: 2 sprays each nostril for 1 dose | 78 |
| Mometasone Furoate Nasal Spray Day 8 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days | 78 |
| Placebo Day 8 Placebo: 2 sprays each nostril for 7 days | 77 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray Day 1 | Placebo Day 1 | Mometasone Furoate Nasal Spray Day 8 | Placebo Day 8 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 11.1 | 36.3 years STANDARD_DEVIATION 10.1 | 36.9 years STANDARD_DEVIATION 10.2 | 38.9 years STANDARD_DEVIATION 11.2 | 37.6 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 45 Participants | 46 Participants | 40 Participants | 44 Participants | 175 Participants |
| Sex: Female, Male Male | 32 Participants | 32 Participants | 38 Participants | 33 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 77 | 1 / 78 | 6 / 78 | 4 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 78 | 0 / 78 | 0 / 77 |
Outcome results
Primary
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.
Time frame: Baseline and 6 hours following initial dosing
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray 200 mcg | Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | -2.01 score on a scale | Standard Error 0.23 |
| Placebo | Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | -1.86 score on a scale | Standard Error 0.23 |
p-value: 0.625ANCOVA