Trial Outcomes & Findings for Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (NCT NCT02631551)
NCT ID: NCT02631551
Last Updated: 2018-09-25
Results Overview
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1180 participants
Primary outcome timeframe
14 days
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
GSP 301 NS
2 sprays in each nostril twice daily for 14 days
|
Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
|
Mometasone Furoate NS
2 sprays in each nostril twice daily for 14 days
|
GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
302
|
297
|
294
|
287
|
|
Overall Study
COMPLETED
|
289
|
278
|
283
|
276
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
11
|
11
|
Reasons for withdrawal
| Measure |
GSP 301 NS
2 sprays in each nostril twice daily for 14 days
|
Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
|
Mometasone Furoate NS
2 sprays in each nostril twice daily for 14 days
|
GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
5
|
|
Overall Study
Protocol deviation
|
3
|
6
|
3
|
0
|
|
Overall Study
Non-compliance with study procedures
|
0
|
0
|
1
|
1
|
|
Overall Study
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
|
Overall Study
Other, specific reasons not collected
|
5
|
7
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Baseline characteristics by cohort
| Measure |
GSP 301 NS
n=302 Participants
2 sprays in each nostril twice daily for 14 days
|
Olopatadine HCl NS
n=297 Participants
2 sprays in each nostril twice daily for 14 days
|
Mometasone Furoate NS
n=294 Participants
2 sprays in each nostril twice daily for 14 days
|
GSP 301 Placebo NS
n=287 Participants
2 sprays in each nostril twice daily for 14 days
|
Total
n=1180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
39.3 years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
762 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
418 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
915 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The Full Analysis Set (FAS) was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
Outcome measures
| Measure |
GSP 301 NS
n=299 Participants
2 sprays in each nostril twice daily for 14 days
|
Olopatadine HCl NS
n=294 Participants
2 sprays in each nostril twice daily for 14 days
|
Mometasone Furoate NS
n=294 Participants
2 sprays in each nostril twice daily for 14 days
|
GSP 301 Placebo NS
n=283 Participants
2 sprays in each nostril twice daily for 14 days
|
|---|---|---|---|---|
|
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Baseline
|
10.1 units on a scale
Standard Deviation 1.2
|
10.3 units on a scale
Standard Deviation 1.3
|
10.2 units on a scale
Standard Deviation 1.2
|
10.2 units on a scale
Standard Deviation 1.2
|
|
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Change from baseline to end of treatment
|
-3.6 units on a scale
Standard Deviation 3.2
|
-3.2 units on a scale
Standard Deviation 3.1
|
-3.5 units on a scale
Standard Deviation 3.3
|
-2.8 units on a scale
Standard Deviation 3.2
|
Adverse Events
GSP 301 NS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Olopatadine HCl NS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mometasone Furoate NS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSP 301 Placebo NS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSP 301 NS
n=302 participants at risk
2 sprays in each nostril twice daily for 14 days
|
Olopatadine HCl NS
n=297 participants at risk
2 sprays in each nostril twice daily for 14 days
|
Mometasone Furoate NS
n=294 participants at risk
2 sprays in each nostril twice daily for 14 days
|
GSP 301 Placebo NS
n=287 participants at risk
2 sprays in each nostril twice daily for 14 days
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.33%
1/302 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.
|
0.00%
0/297 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.
|
0.00%
0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.
|
0.00%
0/287 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the CRO/Sponsor.
- Publication restrictions are in place
Restriction type: OTHER