Seasonal Allergic Rhinitis (SAR)
Conditions
Brief summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
Interventions
DRUGGSP 301 NS
2 spray in each nostril twice daily for 14 days
DRUGGOM-NS
2 spray in each nostril twice daily for 14 days
DRUGGMM-2 NS
2 spray in each nostril twice daily for 14 days
2 spray in each nostril twice daily for 14 days
Sponsors
Glenmark Specialty S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant females who are 12 years of age and older. * Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen) * A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).
Exclusion criteria
* Pregnant or lactating women. * History of anaphylaxis and/or other severe local reaction(s) to skin testing. * History of positive test for HIV, Hepatitis B or Hepatitis C infection. * Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. * Subjects with an active pulmonary disorder or infection. * Subjects with posterior subcapsular cataracts or glaucoma * Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline and day 14 | The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSP 301 Placebo NS 2 sprays/nostril twice daily for 14 days | 293 |
| GSP 301 NS 2 sprays/nostril twice daily for 14 days | 293 |
| Olopatadine HCl NS 2 sprays/nostril twice daily for 14 days | 293 |
| Mometasone Furoate NS 2 sprays/nostril twice daily for 14 days | 293 |
| Total | 1,172 |
Baseline characteristics
| Characteristic | GSP 301 Placebo NS | GSP 301 NS | Olopatadine HCl NS | Mometasone Furoate NS | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 14.93 | 39.9 years STANDARD_DEVIATION 14.91 | 39.9 years STANDARD_DEVIATION 14.62 | 39.2 years STANDARD_DEVIATION 14.86 | 39.6 years STANDARD_DEVIATION 14.81 |
| Sex: Female, Male Female | 176 Participants | 202 Participants | 189 Participants | 170 Participants | 737 Participants |
| Sex: Female, Male Male | 117 Participants | 91 Participants | 104 Participants | 123 Participants | 435 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 | 0 / 294 | 0 / 294 | 0 / 294 | 0 / 293 |
| serious Total, serious adverse events | 1 / 294 | 0 / 294 | 2 / 294 | 1 / 293 |
Outcome results
Primary
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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).
Time frame: Baseline and day 14
Population: The 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSP 301 Placebo NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline | 10.3 units on a scale | Standard Deviation 1.2 |
| GSP 301 Placebo NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Change from baseline to end of treatment | -2.9 units on a scale | Standard Deviation 3.2 |
| GSP 301 NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Change from baseline to end of treatment | -4.3 units on a scale | Standard Deviation 3.1 |
| GSP 301 NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline | 10.1 units on a scale | Standard Deviation 1.2 |
| Olopatadine HCl NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline | 10.2 units on a scale | Standard Deviation 1.3 |
| Olopatadine HCl NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Change from baseline to end of treatment | -3.6 units on a scale | Standard Deviation 3.3 |
| Mometasone Furoate NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Baseline | 10.2 units on a scale | Standard Deviation 1.3 |
| Mometasone Furoate NS | Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | Change from baseline to end of treatment | -3.5 units on a scale | Standard Deviation 3.5 |
p-value: <0.001ANCOVA
p-value: 0.028ANCOVA
p-value: 0.019ANCOVA
p-value: <0.001ANCOVA
p-value: 0.002ANCOVA