Seasonal Allergic Rhinitis
Conditions
Brief summary
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
Interventions
DRUGSPARC Placebo
Placebo
DRUGSPARC1310 I
SPARC1310 I
DRUGSPARC1310 II
SPARC1310 II
DRUGSPARC1310 III
SPARC1310 III
Sponsors
Sun Pharma Advanced Research Company Limited
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
* Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis * Participants able to understand and willing to sign the informed consent form
Exclusion criteria
* Anotomical deviations of the nasal septum that significantly impair ventilation or airflow * Pregnant or nursing women * Positive serology for infectious disease (Hepatitis B or C, HIV) at screening * Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Symptom Score From Baseline to Day 14. | Baseline to Day 14 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPARC Placebo Baseline characteristics: Age | 56 |
| SPARC1310 I Baseline characteristics: Age | 55 |
| SPARC1310 II S0597 mid dose: S0597 mid dose | 56 |
| SPARC1310 III S0597 high dose: S0597 high dose | 55 |
| Total | 222 |
Baseline characteristics
| Characteristic | SPARC Placebo | SPARC1310 I | SPARC1310 II | SPARC1310 III | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 10.8 | 39 years STANDARD_DEVIATION 9.5 | 39 years STANDARD_DEVIATION 10.9 | 38 years STANDARD_DEVIATION 10.6 | 39 years STANDARD_DEVIATION 10.4 |
| Age, Customized | 38 years | 36 years | 38 years | 37 years | 37 years |
| Sex: Female, Male Female | 41 Participants | 29 Participants | 36 Participants | 30 Participants | 136 Participants |
| Sex: Female, Male Male | 15 Participants | 26 Participants | 20 Participants | 25 Participants | 86 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 | 2 / 56 | 3 / 55 | 4 / 56 | 4 / 55 |
| serious Total, serious adverse events | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 55 |
Outcome results
Primary
Change in Total Nasal Symptom Score From Baseline to Day 14.
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.
Time frame: Baseline to Day 14
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Nasal Symptom Score From Baseline to Day 14. | -2.70 units on a scale | Standard Error 0.381 |
| S0597 Low Dose | Change in Total Nasal Symptom Score From Baseline to Day 14. | -4.05 units on a scale | Standard Error 0.378 |
| S0597 Mid Dose | Change in Total Nasal Symptom Score From Baseline to Day 14. | -4.72 units on a scale | Standard Error 0.378 |
| S0597 High Dose | Change in Total Nasal Symptom Score From Baseline to Day 14. | -4.05 units on a scale | Standard Error 0.385 |