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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.

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. - Clinical Trial, efficacy of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005154
Enrollment
120
Registered
2011-03-01
Start date
2011-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese cedar pollinosis

Interventions

Fluticasone furoate puff per nostril once a day 110 micro gram is administered from the beginning of pollinosis symptoms as a first-line drug. 60mg of fexofenadine orally twice a day can be used as

Sponsors

Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)A history of Japanese cedar pollinosis for at least one season before study entry. 2)Positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2. 3)Mild / severe nasal symptoms with pollinosis in ARIA 4)Written informed consent is required.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Rhinoconjunctivitis QOL Questionaire score(RQLQ,JRQLQ), The Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Total ocular symptom score,

Countries

Japan

Contacts

Public ContactTomokazu Matsuoka

University of Yamanashi Department of Otorhinolaryngology, Head & Neck Surgery

tmatsuyamanashi@yahoo.co.jp055-273-6769

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026