Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-301)
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ClinicalTrials.gov Identifier: NCT02631551 |
Recruitment Status :
Completed
First Posted : December 16, 2015
Results First Posted : August 15, 2018
Last Update Posted : September 25, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seasonal Allergic Rhinitis | Drug: GSP 301 NS Drug: Olopatadine HCl NS Drug: Mometasone furoate NS Drug: GSP 301 Placebo NS | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR) |
Study Start Date : | March 2016 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: GSP 301 NS |
Drug: GSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days |
Active Comparator: Olopatadine HCl NS |
Drug: Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days |
Active Comparator: Mometasone furoate NS |
Drug: Mometasone furoate NS
2 sprays in each nostril twice daily for 14 days |
Placebo Comparator: GSP 301 Placebo NS |
Drug: GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days |
- Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. [ Time Frame: 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).

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 spring allergy season (tree/grass 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).
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631551

Study Director: | Sudeesh Tantry, PhD | Glenmark Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Glenmark Specialty S.A. |
ClinicalTrials.gov Identifier: | NCT02631551 |
Other Study ID Numbers: |
GPL/CT/2014/016/III |
First Posted: | December 16, 2015 Key Record Dates |
Results First Posted: | August 15, 2018 |
Last Update Posted: | September 25, 2018 |
Last Verified: | August 2018 |
Seasonal Allergic Rhinitis |
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mometasone Furoate Olopatadine Hydrochloride Anti-Inflammatory Agents |
Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |