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
- Conditions
- Japanese cedar pollinosis
- Registration Number
- JPRN-UMIN000003374
- 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
- 50
Not provided
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
Name Time Method Apnea hypopnea index, The Pittsburgh Sleep Quality Index
- Secondary Outcome Measures
Name Time Method Total nasal symptom score, Total ocular symptom score, Rhinoconjunctivitis QOL Questionaire score