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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Specialty S.A.
• Treatments: Mometasone Furoate; Olopatadine Hydrochloride

Criteria

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