The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
345
Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.
Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks.
Placebo nasal spray administered for 4 weeks.
Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline, and Days 1 through 15 (average of 15 days of treatment)
Number of Participants Who Experienced ≥1 Adverse Event
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.
Time frame: Up to 31 Days
Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.
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Time frame: Up to 31 Days
Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Response To Therapy At Day 4 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 4
Response To Therapy At Day 8 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 8
Response To Therapy At Day 15 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 15
Response To Therapy At Day 22 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 22
Response To Therapy At Day 29 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 29
Response To Therapy At Day 4 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 4
Response To Therapy At Day 8 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 8
Response To Therapy At Day 15 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 15
Response To Therapy At Day 22 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 22
Response To Therapy At Day 29 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 29