Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis

UMIN ID: UMIN000000583

Registered date:05/02/2007

Basic Information

• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2007/02/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Medical treatment is started before the beginning of pollen scattering. Two pranlukast capsules twice a day, after breakfast and dinner (total 4 pranlukast capsules/day) are orally administered from 3rd or 4th Feb. to 31st Mar. or 1st Apr. If necessary, drugs at the same time are used according to"Practical Guideline for the Management of Allergic Rhinitis in Japan" from 17th or 18th Feb. to 31st Mar. or 1st Apr.
Medical treatment is started before the beginning of pollen scattering. Two placebo capsules twice a day, after breakfast and dinner (total 4 placebo capsules /day) are orally administered from 3rd or 4th Feb. to 3rd or 4th Mar. After that, Two pranlukast capsules twice a day, after breakfast and dinner (total 4 pranlukast capsules/day) are orally administered from 3rd or 4th Mar. to 31st Mar. or 1st Apr. If necessary, drugs at the same time are used according to "Practical Guideline for the Management of Allergic Rhinitis in Japan" from 17th or 18th Feb. to 31st Mar. or 1st Apr.

Outcome(s)

• Primary Outcome: Symptom-medication score (symptomscore+medication score)
• Secondary Outcome: Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) any other disease, nasal polyp, acute/chronic rhinitis, sinusitis et al 2) use of any anti-histamine drugs, anti-allergy drugs, nasal steroid drugs et al at the beginning of the study 3) buildup phase of immunotherapy to Japanese cedar pollen 4) pregnancy, potential pregnancy, or lactation 5) the others, inappropriate to this study by the judgment of doctor

Related Information

• Primary Sponsor: Group study of Early Intervention of Pollinosis with Pranlukast
• Source(s) of Monetary Support: Japan Allergy Foundation