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Completed

NCT Number: NCT02318303

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glenmark Investigational Site 10, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Aged ≥12 years and older inclusive of either sex.
  • 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
  • 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:

  • Pregnant or lactating women.
  • Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
  • 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.
  • History of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  • Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  • Subjects with an active pulmonary disorder or infection.
  • Subjects with posterior subcapsular cataracts or glaucoma.

Treatment and study plan

GSP 301-1 NS (QD)

Drug

GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301-2 NS (BID)

Drug

GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301 Placebo NS

Drug

GSP 301 placebo NS administered as 2 sprays/nostril

Olopatadine HCl-1 NS (QD)

Drug

Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril

Olopatadine HCl-2 NS (BID)

Drug

Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril

Mometasone Furoate-1 NS (QD)

Drug

Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril

Mometasone Furoate-2 NS (BID)

Drug

Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Primary outcomes

  1. Change in rTNSS From Baseline to End of Treatment

    Time frame: 14 days

    Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.

    The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.

    The severity scale for each symptom evaluation was defined as follows:

    • 0 = absent (no sign/symptom evident)
    • 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
    • 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
    • 3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study title

A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2014
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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