A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis

UMIN ID: UMIN000001644

Registered date:17/01/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2009/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Regular use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril (total 200 ug/day) every morning from the onset of nasal symptoms.
As-needed use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril once a day (total 200 ug/day) in case of the patient having troublesome nasal symptoms.

Outcome(s)

• Primary Outcome: Overall quality of life score of Rhinoconjunctivitis Quality of Life Questionnire.
• Secondary Outcome: 1) Each score of seven domains of RQLQ. 2) Two summary scores (PCS and MCS) of SF-36 v2. 3) Each severity score of four daily nasal symptoms (runny nose, itchy nose , stuffy nose, and sneezing). 4) Total nasal symptom score (the sum of four nasal symptom scores). 5) Each severity score of three daily ocular symptoms (eye itchiness, eye redness, and tearing). 6) Total ocular symptom score (the sum of three ocular symptom scores).

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 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 deflected nasal septum, sinusitis, or nasal polyps which cause a barrier to evaluate nasal symptoms. 7) Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma. 8) Patients with severe cardiac, hepatic, kidney, or hematological disease. 9) A history of hypersensitivity to mometasone furoate hydrate, loratadine, or sodium cromoglycate. 10) Pregnant or lactating women and women who may be pregnant. 11) Taking a drug of erythromycin or cimetidine.

Related Information

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