Seasonal Allergic Rhinitis
Conditions
Keywords
Seasonal Allergic Rhinitis
Brief summary
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
Interventions
DRUGGSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
DRUGOlopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
DRUGMometasone furoate NS
2 sprays in each nostril twice daily for 14 days
2 sprays in each nostril twice daily for 14 days
Sponsors
Glenmark Specialty S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 12 years and older inclusive of either sex. 2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen) 3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).
Exclusion criteria
1. Pregnant or lactating women. 2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period. 3. History of anaphylaxis and/or other severe local reaction(s) to skin testing. 4. History of positive test for HIV, Hepatitis B or Hepatitis C infection. 5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 6. Subjects with an active pulmonary disorder or infection. 7. Subjects with posterior subcapsular cataracts or glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | 14 days | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSP 301 NS 2 sprays in each nostril twice daily for 14 days | 302 |
| Olopatadine HCl NS 2 sprays in each nostril twice daily for 14 days | 297 |
| Mometasone Furoate NS 2 sprays in each nostril twice daily for 14 days | 294 |
| GSP 301 Placebo NS 2 sprays in each nostril twice daily for 14 days | 287 |
| Total | 1,180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 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 | Non-compliance with study drug | 1 | 0 | 0 | 0 |
| Overall Study | Non-compliance with study procedures | 0 | 0 | 1 | 1 |
| Overall Study | Other, specific reasons not collected | 5 | 7 | 2 | 2 |
| Overall Study | Protocol deviation | 3 | 6 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 5 |
Baseline characteristics
| Characteristic | GSP 301 NS | Total | GSP 301 Placebo NS | Mometasone Furoate NS | Olopatadine HCl NS |
|---|---|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 15.4 | 39.3 years STANDARD_DEVIATION 15.3 | 39.4 years STANDARD_DEVIATION 14.8 | 38.7 years STANDARD_DEVIATION 16.3 | 39.6 years STANDARD_DEVIATION 14.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 20 Participants | 7 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 230 Participants | 48 Participants | 59 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 241 Participants | 915 Participants | 231 Participants | 224 Participants | 219 Participants |
| Sex: Female, Male Female | 201 Participants | 762 Participants | 182 Participants | 198 Participants | 181 Participants |
| Sex: Female, Male Male | 101 Participants | 418 Participants | 105 Participants | 96 Participants | 116 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 | 0 / 302 | 0 / 297 | 0 / 294 | 0 / 287 |
| other Total, other adverse events | 0 / 302 | 0 / 297 | 0 / 294 | 0 / 287 |
| serious Total, serious adverse events | 1 / 302 | 0 / 297 | 0 / 294 | 0 / 287 |
Outcome results
Primary
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
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).
Time frame: 14 days
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSP 301 NS | 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 |
| GSP 301 NS | 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 |
| Olopatadine HCl NS | 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 | -3.2 units on a scale | Standard Deviation 3.1 |
| Olopatadine HCl NS | Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Baseline | 10.3 units on a scale | Standard Deviation 1.3 |
| Mometasone Furoate NS | Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Baseline | 10.2 units on a scale | Standard Deviation 1.2 |
| Mometasone Furoate NS | 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 | -3.5 units on a scale | Standard Deviation 3.3 |
| GSP 301 Placebo NS | Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Baseline | 10.2 units on a scale | Standard Deviation 1.2 |
| GSP 301 Placebo NS | 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 | -2.8 units on a scale | Standard Deviation 3.2 |
Comparison: GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.p-value: <0.0001Mixed Models Analysis
Comparison: GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.p-value: 0.0029Mixed Models Analysis
Comparison: GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.p-value: 0.0587Mixed Models Analysis
Comparison: Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.p-value: 0.0755Mixed Models Analysis
Comparison: Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.p-value: 0.0043Mixed Models Analysis