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Efficacy and Safety of Grass-SPIRE Registration Study

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: NCT02795273
Recruitment Status : Withdrawn (Decision made to stop study following availability of results from another study)
First Posted : June 10, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Circassia Limited

Brief Summary:
The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

Condition or disease Intervention/treatment Phase
Rhinitis Conjunctivitis Drug: Grass-SPIRE Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis
Study Start Date : May 2016
Estimated Primary Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Grass-SPIRE
Eight intradermal injections of Grass-SPIRE
Drug: Grass-SPIRE
Placebo Comparator: Placebo
Eight intradermal injections of Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Combined Score of symptoms and allergy medication [ Time Frame: Approximately 66 weeks ]
    Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication

  2. Safety of Grass-SPIRE [ Time Frame: Approximately 66 weeks ]
    Measurement of adverse events


Secondary Outcome Measures :
  1. Symptom Scores [ Time Frame: Approximately 66 weeks ]
    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects

  2. Rescue Medication Use [ Time Frame: Approximately 66 weeks ]
    Use of allergy medication to help allergy symptoms

  3. Quality of Life [ Time Frame: Approximately 66 weeks ]
    Assessment of Quality of Life measured by responses to a questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
  • Score of ≤ 21 on RCAT questionnaire
  • Rye grass specific IgE of ≥ 0.7 kU/L
  • Positive skin prick test to Rye grass whole allergen extract

Exclusion Criteria:

  • History or findings of significant disease
  • Asthma requiring GINA Step 3 or higher treatment
  • History of severe drug allergy, severe angioedema or systemic allergic reaction
  • Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
  • Contraindications for administration of epinephrine

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): NCT02795273


Locations
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United States, Ohio
Canton, Ohio, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45231
Sponsors and Collaborators
Circassia Limited
Investigators
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Principal Investigator: David Bernstein, MD University of Cincinnati
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Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02795273    
Other Study ID Numbers: TG005
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Circassia Limited:
Rhinitis
Conjunctivitis
Grass
Allergy
Additional relevant MeSH terms:
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Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases