Seasonal Allergic Rhinitis
Conditions
Brief summary
This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.
Interventions
DRUGMometasone furoate nasal spray
Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning
DRUGPlacebo
Two sprays in each nostril in the morning
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
* 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). 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 ECG results. Clinical laboratory test (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. * A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements. * A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.
Exclusion criteria
* A history of anaphylaxis and/or other severe local reaction(s) to skin testing. * A subject with asthma who require 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 have 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 have 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. * Use of any drug in an investigational protocol in the 30 days before the Screening Visit. * A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit. * Pregnant or nursing females. * Family member of the investigation study staff. * Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries. * Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment. * A subject whose ability to provide informed consent is compromised. * A subject with a history of noncompliance with medications or treatment protocols.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Screening through 15 days daily | TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and 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 Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Screening through 15 days daily | 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 the scale is 9. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Screening through 15 days daily | Nasal congestion was one of the symptoms measures 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 | Screening through 15 days daily | 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 in the morning. Each spray is equal to 50 mcg. | 220 |
| Placebo Two sprays in each nostril once daily | 209 |
| Total | 429 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Did not meet protocol eligibility | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray (MFNS) | Total | Placebo |
|---|---|---|---|
| Age, Customized 12 - <18 years | 31 participants | 55 participants | 24 participants |
| Age, Customized 18 - <65 years | 184 participants | 365 participants | 181 participants |
| Age, Customized 6 - <12 years | 0 participants | 1 participants | 1 participants |
| Age, Customized >=65 years | 5 participants | 8 participants | 3 participants |
| Sex: Female, Male Female | 132 Participants | 257 Participants | 125 Participants |
| Sex: Female, Male Male | 88 Participants | 172 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 220 | 0 / 209 |
| serious Total, serious adverse events | 0 / 220 | 0 / 209 |
Outcome results
Primary
Change From Baseline in 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, and 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: Screening through 15 days daily
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline TNSS | 9.31 Score on a scale | Standard Deviation 1.6 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Change from Baseline in TNSS | -2.54 Score on a scale | Standard Deviation 1.99 |
| Placebo | Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline TNSS | 9.31 Score on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Change from Baseline in TNSS | -1.66 Score on a scale | Standard Deviation 1.99 |
p-value: <0.001ANCOVA
Primary
Change From Baseline in 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 the scale is 9.
Time frame: Screening through 15 days daily
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline TOSS | 6.78 Score on a scale | Standard Deviation 1.46 |
| Mometasone Furoate Nasal Spray (MFNS) | Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Change from Baseline in TOSS | -1.71 Score on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline TOSS | 6.74 Score on a scale | Standard Deviation 1.46 |
| Placebo | Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Change from Baseline in TOSS | -1.37 Score on a scale | Standard Deviation 1.6 |
p-value: 0.026ANCOVA
Secondary
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Nasal congestion was one of the symptoms measures 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: Screening through 15 days daily
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 | 2.60 Score on a scale | Standard Deviation 0.38 |
| 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 | -0.59 Score on a scale | Standard Deviation 0.53 |
| Placebo | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline Nasal Congestion Score | 2.62 Score on a scale | Standard Deviation 0.38 |
| 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 Score on a scale | Standard Deviation 0.53 |
p-value: <0.001ANCOVA
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: Screening through 15 days daily
Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 | Baseline PNIF | 93.12 liters/minute | Standard Deviation 41.3 |
| 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 | 16.55 liters/minute | Standard Deviation 36.9 |
| Placebo | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline PNIF | 91.96 liters/minute | Standard Deviation 41.3 |
| Placebo | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Change from Baseline in PNIF | 12.59 liters/minute | Standard Deviation 36.9 |
p-value: 0.269ANCOVA
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. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.
| 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 | 4.27 Score on a scale | Standard Deviation 1.01 |
| 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 | -1.81 Score on a scale | Standard Deviation 1.36 |
| 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 | 4.28 Score on a scale | Standard Deviation 1.01 |
| 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 | -1.08 Score on a scale | Standard Deviation 1.36 |
p-value: <0.001ANCOVA