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A double-blind, placebo-controlled, single-center, randomized, parallel-group clinical trial, efficacy of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis.

Phase 4
Conditions
Japanese cedar pollinosis
Registration Number
JPRN-UMIN000005154
Lead Sponsor
Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

1)Taking any immunosuppressive drugs or systemic steroid drugs within six months before study entry. 2)Taking any antibiotics within two weeks before study entry. 3)Taking any anti-allergy drugs within two weeks before study entry. 4)Using any anti-allergy nasal drops within two weeks before study entry. 5)Under treatment of buildup phase of specific immunotherapy. 6)Patients with severe deflected nasal septum, sinusitis, or nasal polyps. 7)Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma. 8)Patients with severe cardiac, hepatic, kidney disease. 9)A history of hypersensitivity to fluticasone furoate, loratadine. 10)Pregnant or lactating women and women who may be pregnant.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total nasal symptom score (the sum of the severity score of 4 daily nasal symptoms; itchy nose, runny nose, stuffy nose, and sneezing. score range 0-12.)
Secondary Outcome Measures
NameTimeMethod
Rhinoconjunctivitis QOL Questionaire score(RQLQ,JRQLQ), The Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Total ocular symptom score,
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