Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-301)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: GSP 301 NS; Drug: GSP 301 Placebo NS; Drug: Olopatadine HCl NS; Drug: Mometasone furoate NS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02631551

GPL/CT/2014/016/III

Details and patient eligibility

About

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

Enrollment: 1,180 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,180 participants in 4 patient groups, including a placebo group

GSP 301 NS

Experimental group

Treatment:

Drug: GSP 301 NS

Olopatadine HCl NS

Active Comparator group

Treatment:

Drug: Olopatadine HCl NS

Mometasone furoate NS

Active Comparator group

Treatment:

Drug: Mometasone furoate NS

GSP 301 Placebo NS

Placebo Comparator group

Treatment:

Drug: GSP 301 Placebo NS