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

A double-blind, placebo-controlled, single-center, randomized, parallel-group clinical trial, the timing of early intervention with Fluticason Furoate for patients with Japanese cedar pollinosis. - Clinical Trial, the timing 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-UMIN000012861

Enrollment

150

Registered

2014-01-15

Start date

2014-01-15

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 1st Feb. 60mg of fexofenadine orally twice a day can be used as a backup drug. Placebo dreg puff per nostril once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The 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

Secondary

Measure	Time frame
Rhinoconjunctivitis QOL Questionaire score(RQLQ,JRQLQ), The Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Total ocular symptom score, mRNA expression on nasal mucosa	—

Primary

Measure	Time 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.)	—

Countries

Japan

Contacts

Public ContactTomokazu Matsuoka

University of Yamanashi Department of Otorhinolaryngology, Head & Neck Surgery

tmatsu@yamanashi.ac.jp055-273-6769

Outcome results

None listed

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