Efficacy of bilastine on switching treatment in patients with chronic spontaneous urticaria: A comparison study

JRCT ID: jRCTs051180105

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic spontaneous urticaria
• Date of first enrollment: 24/07/2019
• Target sample size: 150
• Study type: Interventional

Intervention(s)

(1) Group A: Increasing H1-antihistamines to 2-fold
H1RA (regular dose) administered orally before registration is increasing up to 2-fold and orally administered. The increasing up to 2-fold is started at the first time after randomization.The number of oral administration during the day do not change. The administration period is 7 days, taken on a daily basis from Day 1 (first prescription day). For medications administered twice a day, it is taken orally until morning of Day 8.
(2) Group B: Switched to the regimen of bilastine
20 mg bilastine is orally administered once daily at least 1 hour before dinner. The administration period is 7 days, taken on a daily basis from Day 1 (first prescription day)

Outcome(s)

• Primary Outcome: Average value of TSS at Day 5-7

Secondary Outcome

1.Efficacy evaluation items
(1)UAS7
(2)Change from baseline in total DLQI score at Week 1 after intervention
(3)Change from baseline (average TSS for 3 days before intervention) in average TSS between Day 5-7 after intervention
2.Safety assessment items
(1)Change from baseline in JESS score at Week 1 after intervention (important secondary evaluation item)
(2)Presence or absence of adverse event after intervention

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients aged 20 years or older at the time of acquisition consent
(2)Patients diagnosed with chronic urticaria for which second-generation non-sedative or mild-sedative antihistamines (regular dose) is not sufficiently effective at the time of acquisition consent.
(3)Patients with chronic urticaria with pruritus or wheal continuation despite continued treatment with unchanged second-generation non-sedating or mild-sedative antihistamines (regular dose) for more than 1 week prior to obtaining consent.
(Second generation non-sedating antihistamines include fexofenadine hydrochloride, levocetirizine hydrochloride, olopatadine hydrochloride, bepotastine besylate, loratadine, cetirizine hydrochloride, epinastine hydrochloride, ebastine, lupantadine fumarate)
(4)Patients with UCT score of 11 or less on screening phase
(5)Patients who obtained document consent regarding their own voluntary participation in this clinical study
(6)Even if symptoms (pruritus or wheal) improve while taking the test drug or control drug, patients who can take the test drug or control drug for 7 days.

Exclude criteria

(1)Patients with urticaria, other than chronic spontaneous urticaria, with an identifiable trigger/cause. If triggering factors are specified and the site or timing of onsets of symptom due to the factor can be clearly distinguished from chronic spontaneous urticaria which is the target disease of this clinical study, it does not conflict with the exclusion criteria.
(2)Patients with a skin disease accompanied by chronic pruritus other than chronic urticaria. (eczema, contact dermatitis, atopic dermatitis)
(3)Patients with hypersensitivity for bilastine
(4)Patients with chronic, uncontrolled medical condition that may increase the risk of research subjects participating in clinical research with the judgement of research investigator or research team physicians.
(5)Pregnant or lactating women
(6)Patients treated with bilastine, adrenocorticosteroid, or cyclosporine within 4 week prior to obtaining consent. Patients treated with first generation antihistamines, H2 receptor antagonists, or anti-leukotriene drugs within one week prior to obtaining consent. However, the use of external medicine is permitted.
(7)Patients with chronic spontaneous urticaria treated with omalizumab in the past.
(8)In addition, patients judged inappropriate by research investigator or research team physicians.

Related Information

• Primary Sponsor: Fukunaga Atsushi
• Source(s) of Monetary Support: Taiho Pharmaceutical Co., Ltd.