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The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC Placebo | Placebo Comparator |
| |
| SPARC1310 I | Experimental |
| |
| SPARC1310 II | Experimental |
| |
| SPARC1310 III | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC Placebo | Drug | Placebo |
| |
| SPARC1310 I |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shravanti Bhowmik, MD | Sun Pharma Advanced Research Company Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 1 | Kingston | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27613466 | Derived | Ellis AK, Steacy LM, Joshi A, Bhowmik S, Raut A. Efficacy of the novel nasal steroid S0597 tested in an environmental exposure unit. Ann Allergy Asthma Immunol. 2016 Sep;117(3):310-7. doi: 10.1016/j.anai.2016.07.018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPARC Placebo | SPARC Placebo was administered as sprays/nostril QD |
| FG001 | SPARC1310 I | SPARC1310 I was administered as two sprays /nostril QD |
| FG002 | SPARC1310 II | SPARC1310 II was administered as two sprays/nostril QD |
| FG003 | SPARC1310 III | SPARC1310 III was administered as two sprays/nostril QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPARC Placebo | Baseline characteristics: Age |
| BG001 | SPARC1310 I | Baseline characteristics: Age |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPARC Placebo | SPARC Placebo administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood cortisol decreased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shravanti Bhowmik, MD | SPARC | shravanti.bhowmik@sparcmail.com |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Drug |
SPARC1310 I |
|
| SPARC1310 II | Drug | SPARC1310 II |
|
| SPARC1310 III | Drug | SPARC1310 III |
|
| BG002 |
| SPARC1310 II |
S0597 mid dose: S0597 mid dose |
| BG003 | SPARC1310 III | S0597 high dose: S0597 high dose |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
S0597 mid dose: S0597 mid dose |
| OG003 | S0597 High Dose | S0597 high dose: S0597 high dose |
|
|
| 0 |
| 56 |
| 2 |
| 56 |
| EG001 | SPARC1310 I | SPARC1310 I administration | 0 | 55 | 3 | 55 |
| EG002 | SPARC1310 II | SPARC1310 II administration | 0 | 56 | 4 | 56 |
| EG003 | SPARC1310 III | SPARC1310 III administration | 0 | 55 | 4 | 55 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |