Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (GSP 301-305)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis (SAR)

Treatments: Drug: GSP 301 NS; Drug: GSP 301 Placebo NS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03463031

GSP 301-305

Details and patient eligibility

About

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).

Enrollment: 446 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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446 participants in 2 patient groups, including a placebo group

GSP 301 NS

Experimental group

Description:

Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS

Treatment:

Drug: GSP 301 NS

GSP 301 Placebo NS

Placebo Comparator group

Description:

GSP 301 Placebo nasal spray

Treatment:

Drug: GSP 301 Placebo NS