a multicenter, open-labeled, randomized, parallel-group study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis

UMIN ID: UMIN000000575

Registered date:17/01/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2007/01/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

One fluticasone 50 ug puff per nostril twice a day (total 200 ug/day) is administered from the beginning of pollinosis symptoms to March/31/07 as a first-line drug. Sixty mg of fexofenadine orally twice a day (total 120mg/day) is started as a backup drug , if daily total nasal symptom score is 4 or more for 4 days or more per week.
Oral fexofenadine 60 mg twice a day (total 120 mg/day) is administered from the beginning of pollinosis symptoms to March/31/07 as a first-line drug. One fluticasone 50 ug puff per nostril twice a day (total 200 ug/day) is started as a backup drug, if daily total nasal symptom score is 4 or more for 4 days or more per week.

Outcome(s)

• Primary Outcome: 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: Total ocular symptom score (the sum of the severity score of 3 daily ocular symptoms; eye itchiness, tearing, and eye redness ), Rhinoconjunctivitis QOL Questionaire score

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) use of any anti-allergy drugs at the beginning of the study 2) any other nose/paranasal sinus disease, pharyngitis, laryngitis, respiratory tract infection, asthma 3) a history of glaucoma, gastric ulcer, uncontrollable hypertension/diabetes, hepatitis, malignant tumor 4) buildup phase of specific immunotherapy to Japanese cedar pollen 5) a history of nose/paranasal sinus surgery 6) a history of hypersensitivity to fluticasone propionate or fexofenadine hydrochroride 7) pregnancy, potential pregnancy, or lactation

Related Information

• Primary Sponsor: Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
• Secondary Sponsor: Kyoto University
• Source(s) of Monetary Support: None