Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (GSP 301-303)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: GSP 301 Placebo NS pH 7.0; Drug: GSP 301 NS; Drug: GSP 301 Placebo NS pH 3.7

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709538

GPL/CT/2014/018/III

Details and patient eligibility

About

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)

Enrollment: 601 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 PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

Exclusion criteria

1. Pregnant or lactating women.
2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal 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: Double Blind

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601 participants in 3 patient groups, including a placebo group

GSP 301 NS

Experimental group

Treatment:

Drug: GSP 301 NS

GSP 301 Placebo NS pH 3.7

Placebo Comparator group

Treatment:

Drug: GSP 301 Placebo NS pH 3.7

GSP 301 Placebo NS pH 7.0

Placebo Comparator group

Treatment:

Drug: GSP 301 Placebo NS pH 7.0