Phase 2
N=1,111
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT02318303 ↗Enrolled (actual)
1,111
Serious AEs
0.1%
Results posted
Jun 2017
Primary outcome: Primary: Change in rTNSS From Baseline to End of Treatment — 10.3; 10.4; 10.4; 10.3 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSP 301-1 NS (QD) (Drug); GSP 301-2 NS (BID) (Drug); GSP 301 Placebo NS (Drug); Olopatadine HCl-1 NS (QD) (Drug); Olopatadine HCl-2 NS (BID) (Drug); Mometasone Furoate-1 NS (QD) (Drug); Mometasone Furoate-2 NS (BID) (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in rTNSS From Baseline to End of Treatment |
10.3; 10.4; 10.4; 10.3; 10.4; 10.5 | <0.0001 sig |
Summary
Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.
Eligibility Criteria
Key Inclusion Criteria
- Aged ≥12 years and older inclusive of either sex.
- 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 study season for the mountain cedar pollen
- 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).
Key Exclusion Criteria
- Pregnant or lactating women.
- Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
- History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
- 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.
Data sourced from ClinicalTrials.gov (NCT02318303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.