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

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 - a randomized study comparing fluticasone propionate nasal spray and oral fexofenadine hydrochroride as early seasonal treatment for Japanese cedar pollinosis (FOREST study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000575

Enrollment

120

Registered

2007-01-17

Start date

2007-01-01

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

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 t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) a history of Japanese cedar pollinosis for at least 2 seasons before study entry 2) positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2 3) mild nasal symptoms with pollinosis (daily total nasal symptom score <=2) in early pollen season

Exclusion criteria

Exclusion 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

Design outcomes

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.)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactZensei Matsuzaki

University of Yamanashi Department of Otorhinolaryngology, Head & Neck Surgery

055-273-6769

Outcome results

None listed

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