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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02795273
Other study ID # TG005
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received May 5, 2016
Last updated June 21, 2016
Start date May 2016

Study information

Verified date June 2016
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Grass-SPIRE

Placebo


Locations

Country Name City State
United States Bernstein Clinical Research Center, LLC Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Circassia Limited

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Combined Score of symptoms and allergy medication Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication Approximately 66 weeks No
Primary Safety of Grass-SPIRE Measurement of adverse events Approximately 66 weeks Yes
Secondary Symptom Scores Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects Approximately 66 weeks No
Secondary Rescue Medication Use Use of allergy medication to help allergy symptoms Approximately 66 weeks No
Secondary Quality of Life Assessment of Quality of Life measured by responses to a questionnaire Approximately 66 weeks No
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