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Study In Adults And Adolescents With Seasonal Allergic Rhinitis

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Hayfever
Seasonal Allergic Rhinitis
Rhinitis, Allergic, Seasonal

Treatments

Drug: fluticasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115622
FFR30003

Details and patient eligibility

About

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Enrollment

304 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent.
  • Outpatient.
  • Females must use appropriate contraception.
  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to allergen.
  • Able to comply with study procedures.
  • Literate.

Exclusion criteria

  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or tobacco.
  • Clinically significant abnormal ECG.
  • Laboratory abnormality.
  • Positive pregnancy test.
  • Allergy to any component of the investigational product.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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