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A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the Treatment of Seasonal allergies

Phase 1
Conditions
Seasonal allergic rhinitis (SAR)
Therapeutic area: Body processes [G] - Immune system processes [G12]
Registration Number
EUCTR2015-004885-27-Outside-EU/EEA
Lead Sponsor
GlaxoSmithKline Research & Development Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
A
Sex
All
Target Recruitment
936
Inclusion Criteria

- Informed consent.

- Outpatient.

- Females of child-bearing potential must use appropriate contraception.

- Diagnosis of seasonal allergic rhinitis to mountain cedar.

- Adequate exposure to allergen.

- Able to comply with study procedures.

- Literate.
Are the trial subjects under 18? yes
Number of subjects for this age range: 81
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 831
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

- Significant concomitant medical condition.

- Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis

- Positive pregnancy test.

- Allergy to any component of the investigational product.

- Tobacco use

- Contact lens use

- Has chickenpox or measles or recent exposure

- Other clinical trial drug exposure in last 30 days

- Affiliation with clinic site

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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