Trial Outcomes & Findings for Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis (NCT NCT01940146)
NCT ID: NCT01940146
Last Updated: 2019-05-03
Results Overview
The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
COMPLETED
PHASE2
222 participants
Baseline to Day 14
2019-05-03
Participant Flow
Participant milestones
| Measure |
SPARC Placebo
SPARC Placebo was administered as sprays/nostril QD
|
SPARC1310 I
SPARC1310 I was administered as two sprays /nostril QD
|
SPARC1310 II
SPARC1310 II was administered as two sprays/nostril QD
|
SPARC1310 III
SPARC1310 III was administered as two sprays/nostril QD
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
56
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
55
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
SPARC Placebo
n=56 Participants
Baseline characteristics: Age
|
SPARC1310 I
n=55 Participants
Baseline characteristics: Age
|
SPARC1310 II
n=56 Participants
S0597 mid dose: S0597 mid dose
|
SPARC1310 III
n=55 Participants
S0597 high dose: S0597 high dose
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
39 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
39 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
38 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
39 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Age, Customized
|
38 years
n=5 Participants
|
36 years
n=7 Participants
|
38 years
n=5 Participants
|
37 years
n=4 Participants
|
37 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 14The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo: Placebo
|
S0597 Low Dose
n=55 Participants
S0597 low dose: S0597 low dose
|
S0597 Mid Dose
n=56 Participants
S0597 mid dose: S0597 mid dose
|
S0597 High Dose
n=55 Participants
S0597 high dose: S0597 high dose
|
|---|---|---|---|---|
|
Change in Total Nasal Symptom Score From Baseline to Day 14.
|
-2.70 units on a scale
Standard Error 0.381
|
-4.05 units on a scale
Standard Error 0.378
|
-4.72 units on a scale
Standard Error 0.378
|
-4.05 units on a scale
Standard Error 0.385
|
Adverse Events
SPARC Placebo
SPARC1310 I
SPARC1310 II
SPARC1310 III
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SPARC Placebo
n=56 participants at risk
SPARC Placebo administration
|
SPARC1310 I
n=55 participants at risk
SPARC1310 I administration
|
SPARC1310 II
n=56 participants at risk
SPARC1310 II administration
|
SPARC1310 III
n=55 participants at risk
SPARC1310 III administration
|
|---|---|---|---|---|
|
Investigations
Blood cortisol decreased
|
3.6%
2/56
|
5.5%
3/55
|
7.1%
4/56
|
7.3%
4/55
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER