Chronic Spontaneous Urticaria (CSU)NCT07365683
Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria
A study testing tab bilastine 20 mg and tab bilastine 20 mg + tab levocetrizine 5 mg in people with Chronic Spontaneous Urticaria (CSU), run by Derma Techno Pakistan at 1 site in Pakistan.
Trial summary
This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- tab bilastine 20 mg and tab bilastine 20 mg + tab levocetrizine 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Aug 2025to 17 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of CSU as per operational definitions.
- Patients already taking Bilastine 20 mg and still getting new lesions.
- UAS7 score >3
- Age range of 18-70 years
- Both male and female patients
Who cannot join
- • women Patients who have already received treatment of CSU other than Bilastine.
- Patients taking oral or topical corticosteroids
- Pregnant or lactating
- Patients with hereditary angioedema, atopic dermatitis, systemic immune disorders, collagen vascular diseases, immunocompromised status, Chronic liver or kidney failures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
combined military hospital ,Okara
Okāra, Punjab Province, 56300
About this study
Official title: A Prospective Randomized Non-blinded Study of Safety and Efficacy of Bilastine Up-dosing (40 mg) Versus Combination of Bilastine (20 mg) With Levocetrizine (5mg) in the Treatment of Chronic Spontaneous Urticaria
This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life.
Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits.
The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Being tested
- tab bilastine 20 mg, tab bilastine 20 mg + tab levocetrizine 5 mg
- Keywords
- up-dosing +combination
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tab bilastine 20 mgDrug
tab bilastine 20 mg given orally twice a day for 6 weeks
tab bilastine 20 mg + tab levocetrizine 5 mgDrug
tab levocitrizine 5 mg given orally at night with combination of tab bilastine 20 mg in the morning for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A (tab bilastine 40mg ) | Active comparator | patients received oral tab bilastine 20 mg twice daily for 6 weeks Receives: Drug: tab bilastine 20 mg |
| Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg ) | Active comparator | patients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks Receives: Drug: tab bilastine 20 mg + tab levocetrizine 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in urticaria severity score (UAS7)
change in urticaria severity score (UAS7) from baseline to 6 weeks UAS7 is a validated composite score assessing daily wheal number and pruritis severity over 7 consecutive days ,with total scores ranging from 0 to 42.
Higher scores indicate more severe urticaria activity and a reduction in score reflects clinical improvement.
Measured: baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start18 Aug 2025
- Primary completion10 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derma Techno Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365683
- Sponsor's protocol ID
- IERC/DER/2024/01
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Non-blinded Study of Safety and Efficacy of Bilastine Up-dosing (40 mg) Versus Combination of Bilastine (20 mg) With Levocetrizine (5mg) in the Treatment of Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07365683
- Acronym / sponsor ID
- IERC/DER/2024/01
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Keywords
- up-dosing +combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Derma Techno PakistanIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life.
Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits.
The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (tab bilastine 40mg ) | Active comparator | Drug: tab bilastine 20 mgpatients received oral tab bilastine 20 mg twice daily for 6 weeks |
| Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg ) | Active comparator | Drug: tab bilastine 20 mg + tab levocetrizine 5 mgpatients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diagnosis of CSU as per operational definitions.
- Patients already taking Bilastine 20 mg and still getting new lesions.
- UAS7 score >3
- Age range of 18-70 years
- Both male and female patients
Key exclusion criteria (4 listed)
- • women Patients who have already received treatment of CSU other than Bilastine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tab bilastine 20 mgtab bilastine 20 mg given orally twice a day for 6 weeks | Drug | Group A (tab bilastine 40mg ) |
| tab bilastine 20 mg + tab levocetrizine 5 mgtab levocitrizine 5 mg given orally at night with combination of tab bilastine 20 mg in the morning for 6 weeks | Drug | Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg ) |
Primary outcome
change in urticaria severity score (UAS7)
Time frame: baseline to 6 weeks
change in urticaria severity score (UAS7) from baseline to 6 weeks UAS7 is a validated composite score assessing daily wheal number and pruritis severity over 7 consecutive days ,with total scores ranging from 0 to 42. Higher scores indicate more severe urticaria activity and a reduction in score reflects clinical improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tab bilastine 20 mg and tab bilastine 20 mg + tab levocetrizine 5 mg in people with Chronic Spontaneous Urticaria (CSU), run by Derma Techno Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in urticaria severity score (UAS7) (time frame: baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.