Efficacy of bilastine on switching treatment in patients with chronic spontaneous urticaria: A comparison study
- Conditions
- Chronic spontaneous urticaria
- Registration Number
- JPRN-jRCTs051180105
- Lead Sponsor
- Fukunaga Atsushi
- Brief Summary
The primary endpoint, the mean TSS at Day5-7 after the start of administration, was smaller than the non-inferiority margin of 0.8, demonstrating the non-inferiority of the bilastine switching group to the 2-fold dose H1RA group. No difference was observed between the two groups in the secondary endpoints of JESS, DLQI, and UAS7.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 129
(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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average value of TSS at Day 5-7
- Secondary Outcome Measures
Name Time Method 1.Efficacy evaluation items<br>(1)UAS7<br>(2)Change from baseline in total DLQI score at Week 1 after intervention<br>(3)Change from baseline (average TSS for 3 days before intervention) in average TSS between Day 5-7 after intervention<br>2.Safety assessment items<br>(1)Change from baseline in JESS score at Week 1 after intervention (important secondary evaluation item)<br>(2)Presence or absence of adverse event after intervention