A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis

UMIN ID: UMIN000001657

Registered date:26/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2009/01/01
• Target sample size: 32
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Botulinum toxin A (20 U, 0.2ml) is injected into each nasal cavity just before the beginning of pollen scattering. Ten mg of loratadine and/ or mometazone nasal spray can be used as a backup drug.
Saline (0.2ml) is injected into each nasal cavity just before the beginning of pollen scattering. Ten mg of loratadine and/ or mometasone nasal spray can be used as a backup drug.

Outcome(s)

• Primary Outcome: Symptom score, symptom-medication score, QOL estimation, rhinomanometry
• Secondary Outcome: adverse events

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1)pregnancy or possibility of pregnancy 2)history of heart disease 3)history of glaucoma 4)history of prostate hypertrophy 5)history of neuro-muscular disease 6)history of stroke 7)accompanying acute rhinitis or sinusitis 8)use of any anti-allergy drugs at the beginning of the study 9)history of nose/sinus surgery 10)prominent deviation of the nasal septum

Related Information

• Primary Sponsor: Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine, University of Yamanash
• Secondary Sponsor: NONE
• Source(s) of Monetary Support: NONE