Clinical Trial Results:
Disease activity controlled dose escalating study to assess the efficacy, and safety of treatment with bilastine 20 mg, 40 mg and 80 mg in chronic spontaneous urticaria.
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Summary
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EudraCT number |
2014-000181-21 |
Trial protocol |
DE |
Global end of trial date |
05 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Feb 2022
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First version publication date |
13 Feb 2022
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Other versions |
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Summary report(s) |
Final Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BUCSU
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Charite - Universitätsmedizin Berlin
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Sponsor organisation address |
Charitéplatz 1 , Berlin, Germany, 10117
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Public contact |
Allergie-Centrum-Charite, Charite - Universitätsmedizin Berlin, +49 030450518042, marcus.maurer@charite.de
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Scientific contact |
Allergie-Centrum-Charite, Charite - Universitätsmedizin Berlin, +49 030450518042, marcus.maurer@charite.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on disease activity in patients with chronic spontaneous urticaria.
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Protection of trial subjects |
A total number of 30 patients with moderate to severe chronic spontaneous urticaria, all of which had previously failed treatment with an antihistamine other than bilastine in standard (licensed) dose, were planned to be included into the study. Until the end of the trial, 31 patients were randomized and analyzed.
The evaluation of efficacy and safety was carried out on the intention-to-treat population.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 May 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
21
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
During the first two weeks (14 2 days) of the study (screening phase) all patients were administered with one tablet bilastine 20 mg daily p.o. as rescue medication. This tablet should only be taken in case of intolerable CSU symptoms and the intake had to be documented in the patient diary. | ||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Bilastine 20/40/80 mg | ||||||
Arm description |
During the first two weeks of the following treatment phase all patients were asked to take one tablet bilastine 20 mg p.o. once daily. In case the patients did not achieve complete response, they changed to 40 mg bilastine p.o. (2 tablets containing bilastine 20 mg once daily) for the next two weeks, while those with complete response stayed on 20 mg bilastine p.o. once daily for the rest of the study. After another two weeks, response to treatment was again reviewed. Those patients who did not achieve complete response to 40 mg bilastine p.o. were further updosed to 80 mg bilastine p.o. (4 tablets containing bilastine 20 mg once daily), while those with complete response stayed on the 40 mg dose p.o. for the rest of the trial. The total duration of the treatment phase was 6 weeks. | ||||||
Arm type |
Active comparator | ||||||
Investigational medicinal product name |
Bilastine
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Investigational medicinal product code |
ATC-Code: R06AX29)
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
20, 40 and 80 mg bilastine
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End points reporting groups
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Reporting group title |
Bilastine 20/40/80 mg
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Reporting group description |
During the first two weeks of the following treatment phase all patients were asked to take one tablet bilastine 20 mg p.o. once daily. In case the patients did not achieve complete response, they changed to 40 mg bilastine p.o. (2 tablets containing bilastine 20 mg once daily) for the next two weeks, while those with complete response stayed on 20 mg bilastine p.o. once daily for the rest of the study. After another two weeks, response to treatment was again reviewed. Those patients who did not achieve complete response to 40 mg bilastine p.o. were further updosed to 80 mg bilastine p.o. (4 tablets containing bilastine 20 mg once daily), while those with complete response stayed on the 40 mg dose p.o. for the rest of the trial. The total duration of the treatment phase was 6 weeks. | ||
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End point title |
Comparison of the rate of complete responders (reduction of the UAS7 by at least 90% (as compared to baseline) or a UAS7 ≤ 3) between the second (20 mg bilastine), fourth (20 mg or 40 mg bilastine) and sixth week (20 mg, 40 mg or 80 mg bilastine) of the t [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The total duration of the treatment phase was 6 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: see final report |
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| No statistical analyses for this end point | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the whole study.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: See final report |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
