Acute UrticariaPhase 2/3CAHISUNCT02565680
Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency
A Phase 2/3 study testing prednisone in people with Acute Urticaria, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Urticaria
- What is being tested?
- prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- urticaria rash no more 24 h duration and no take treatment for urticaria
Who cannot join
- patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED,
- severe infection
- pregnancy
- patients BPCO
- diabetics
- allergy corticosteroids
- refusal to comply
- participate an other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.
Read the detailed description
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.
- Conditions
- Acute Urticaria
- Being tested
- placebo, prednisone
- Keywords
- acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Xyzall 5mg during 5 days + placebo 40mg during 4 days
prednisoneDrug
Xyzall 5mg during 5 days + prednisone 40mg during 4 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days Receives: Drug: placebo |
| prednisone | Experimental | tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score
Measured: 48 hours
Secondary outcomes (5)
Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace
Evolution of intensity pruritus at T0 and T1, J2, J5, J15, J21 and angioedema and rash at T1, J2, J5, J15 and J21 comparing at T0 with nine rule of Wallace
Measured: 21 days
The necessary time to decrease pruritus and rash
The necessary time to decrease pruritus and rash
Measured: 21 days
The frequency of side-effects in either treatment group in 21 days
The frequency of side-effects in either treatment group in 21 days
Measured: 21 days
Recidive of urticaria
The recidive of urticaria
Measured: 21 days
The observance treatment
Observance treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute UrticariaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Barniol, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565680
- Sponsor's protocol ID
- 11 221 02
- Acronym
- CAHISU
- Status last verified
- May 2023
- First submitted
- 22 Jul 2014
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.
PubMed 28476259
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency
- ClinicalTrials.gov ID
- NCT02565680
- Acronym / sponsor ID
- CAHISU / 11 221 02
- Conditions
- Acute Urticaria
- Keywords
- acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.
Detailed description
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebotablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days |
| prednisone | Experimental | Drug: prednisonetablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- urticaria rash no more 24 h duration and no take treatment for urticaria
Key exclusion criteria (8 listed)
- patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED,
- severe infection
- pregnancy
- patients BPCO
- diabetics
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 |
|---|---|---|
| placeboXyzall 5mg during 5 days + placebo 40mg during 4 days | Drug | placebo |
| prednisoneXyzall 5mg during 5 days + prednisone 40mg during 4 days | Drug | prednisone |
Primary outcome
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
Time frame: 48 hours
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score
5 secondary outcomes
Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace
Time frame: 21 days
The necessary time to decrease pruritus and rash
Time frame: 21 days
The frequency of side-effects in either treatment group in 21 days
Time frame: 21 days
Recidive of urticaria
Time frame: 21 days
The observance treatment
Time frame: 21 days
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 23 May 2023.
- Results publication: PubMed 28476259Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.
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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.
Caroline Barniol, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prednisone in people with Acute Urticaria, run by University Hospital, Toulouse at 1 site in France.
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 2 inclusion and 8 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 23 May 2023. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565680, which also lists 1 linked publication.
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 23 May 2023.