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Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02631551
Recruitment Status : Completed
First Posted : December 16, 2015
Results First Posted : August 15, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Glenmark Specialty S.A.

Study Description
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Brief Summary:
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: GSP 301 NS Drug: Olopatadine HCl NS Drug: Mometasone furoate NS Drug: GSP 301 Placebo NS Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
Study Start Date : March 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: GSP 301 NS Drug: GSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
Active Comparator: Olopatadine HCl NS Drug: Olopatadine HCl NS
2 sprays in each nostril twice daily for 14 days
Active Comparator: Mometasone furoate NS Drug: Mometasone furoate NS
2 sprays in each nostril twice daily for 14 days
Placebo Comparator: GSP 301 Placebo NS Drug: GSP 301 Placebo NS
2 sprays in each nostril twice daily for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. [ Time Frame: 14 days ]
    Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 spring allergy season (tree/grass 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).

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 anaphylaxis and/or other severe local reaction(s) to skin testing.
  4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  5. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  6. Subjects with an active pulmonary disorder or infection.
  7. Subjects with posterior subcapsular cataracts or glaucoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631551


Locations
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Sponsors and Collaborators
Glenmark Specialty S.A.
Investigators
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Study Director: Sudeesh Tantry, PhD Glenmark Pharmaceuticals
More Information
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Additional Information:
Efficacy and Safety of Olopatadine/Mometasone Combination Nasal Spray in Patients With Seasonal Allergic Rhinitis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Glenmark Specialty S.A.
ClinicalTrials.gov Identifier: NCT02631551    
Other Study ID Numbers: GPL/CT/2014/016/III
First Posted: December 16, 2015    Key Record Dates
Results First Posted: August 15, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018
Keywords provided by Glenmark Specialty S.A.:
Seasonal Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Olopatadine Hydrochloride
Anti-Inflammatory Agents
Dermatologic Agents
 Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action