To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Olopatadine HCl-2 NS (BID); Drug: GSP 301-1 NS (QD); Drug: GSP 301-2 NS (BID); Drug: Mometasone Furoate-1 NS (QD); Drug: GSP 301 Placebo NS; Drug: Olopatadine HCl-1 NS (QD); Drug: Mometasone Furoate-2 NS (BID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318303

GPL/CT/2014/004/II

IND Number: 123164 (Other Identifier)

Study Number (GSP 301-201) (Other Identifier)

Details and patient eligibility

About

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Enrollment: 1,111 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 study season for the mountain cedar 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).

Key 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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
7. Subjects with an active pulmonary disorder or infection.
8. 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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1,111 participants in 7 patient groups, including a placebo group

GSP 301 Placebo NS

Placebo Comparator group

Treatment:

Drug: GSP 301 Placebo NS

GSP 301-1 NS (QD)

Experimental group

Treatment:

Drug: GSP 301-1 NS (QD)

GSP 301-2 NS (BID)

Experimental group

Treatment:

Drug: GSP 301-2 NS (BID)

Olopatadine HCl-1 NS (QD)

Active Comparator group

Treatment:

Drug: Olopatadine HCl-1 NS (QD)

Olopatadine HCl-2 NS (BID)

Active Comparator group

Treatment:

Drug: Olopatadine HCl-2 NS (BID)

Mometasone Furoate-1 NS (QD)

Active Comparator group

Treatment:

Drug: Mometasone Furoate-1 NS (QD)

Mometasone Furoate-2 NS (BID)

Active Comparator group

Treatment:

Drug: Mometasone Furoate-2 NS (BID)