Open-labeled, randomized, parallel-group study comparing fluticasone furoate nasal spray and oral loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis

Open-labeled, randomized, parallel-group study comparing fluticasone furoate nasal spray and oral loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis - Randomized study comparing fluticasone furoate and loratadine as early seasonal treatment these effects on sleep disorder in patients with Japanese cedar pollinosis (FLEES study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003374

Enrollment

Registered

2010-03-24

Start date

2010-01-01

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. 10 mg of loratadine orally once a day can be used as a

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)BMI<25 5)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

Measure	Time frame
Apnea hypopnea index, The Pittsburgh Sleep Quality Index	—

Secondary

Measure	Time frame
Total nasal symptom score, Total ocular symptom score, Rhinoconjunctivitis QOL Questionaire 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