Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Trial end date: 2018-11-14
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

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

Details

• Lead Sponsor: Glenmark Specialty S.A.

Criteria

Inclusion Criteria:

1. Male and female subjects aged ≥6 to <12 years

2. Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)

3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening

4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening

5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Exclusion Criteria:

1. Females of childbearing potential or pregnant

2. Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

3. History of anaphylaxis and/or other severe local reaction(s) to skin testing

4. History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip

5. Subjects with an active pulmonary disorder or infection.

6. Subjects with posterior subcapsular cataracts or glaucoma