Chronic UrticariaAWARE-LACanNCT02626221
A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)
An observational study of Chronic Urticaria, run by Novartis Pharmaceuticals at 31 sites in 9 countries.
Trial summary
This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Non Interventional Study
- How many people
- 497 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 24 Dec 2014to 21 Mar 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Eligible Latin American Chronic Urticaria adult patients, males and females, with at least one course of H1 antihistamines and is shown to be refractory to this treatment
Who may be able to join
- Men or Women at least 18 years of age or older. Patient has medically confirmed diagnosis of chronic urticaria present for more than 2 months.
- Patient has been treated with at least one course of H1 antihistamines and is refractory to this treatment Patient has provided written informed consent allowing the use of their anonymous data for the purposes of the study
Who cannot join
- Patient is currently participating in a clinical trial. Patient is, in the opinion of the treating physician, unlikely to be available for the full duration of the follow-up period of 24 months
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
Argentina10 sites
Novartis Investigative Site
Buenos Aires, Nueve De Julio, B6500BWQ
Novartis Investigative Site
Buenos Aires, C1425DKG
Novartis Investigative Site
CABA, Buenos Aires, C1062ABK
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1114AAJ
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA
Novartis Investigative Site
Lobos, Buenos Aires
Novartis Investigative Site
Mendoza, M5502EZA
Novartis Investigative Site
Rosario, Santa Fe Province, 2000
Novartis Investigative Site
Rosario, Santa Fe Province, S2000BRH
Novartis Investigative Site
Salta, 4400
Brazil5 sites
Novartis Investigative Site
Alphaville / Barueri, São Paulo, 06454-010
Novartis Investigative Site
Guarulhos, São Paulo, 07051-000
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913
Novartis Investigative Site
Santo André, São Paulo, 09060-650
Novartis Investigative Site
São Paulo, São Paulo, 05437-000
Colombia4 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Bogotá, Cundinamarca
Novartis Investigative Site
Medellín, Antioquia
Novartis Investigative Site
Medellín
Dominican Republic3 sites
Novartis Investigative Site
Santiago de los Caballeros, Republica Dominicana
Novartis Investigative Site
Santo Domingo, Republica Dominicana
Novartis Investigative Site
Santo Domingo
Honduras3 sites
Novartis Investigative Site
San Pedro Sula, 21102
Novartis Investigative Site
San Pedro Sula
Novartis Investigative Site
Tegucigalpa
Costa Rica2 sites
Novartis Investigative Site
San José
Novartis Investigative Site
San Rafael Escazu
Peru2 sites
Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
San Martín de Porres, Lima region, 31
About this study
Official title: A Prospective Non-interventional Study to Collect Real Life Clinical Data on the Impact of Therapy, the Diagnosis and Management of Chronic Urticaria in Patients Refractory to at Least One Course of H1 Antihistamine Therapy
This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks).
In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended.
Read more
The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines.
In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study.
The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment
- Conditions
- Chronic Urticaria
- Being tested
- Non Interventional Study
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional StudyOther
Non Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Single | Single Cohort Study Receives: Other: Non Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CU-Quality of Life Questionnaire Score
The CU-QoL is a validated instrument with established psychometric properties developed specifically for the assessment of the health burden of CU. The 2013 international CU guideline recommends the use of CU-Q2oL for assessing quality of life impairment and monitoring disease activity.
Measured: Last 15 days before each visit
Secondary outcomes (6)
Angioedema Quality of Life Questionnaire (AE-QoL)
For patients with angioedema, the symptom-specific quality of life will be assessed over the course of the study with the Angioedema Quality of Life Questionnaire (AE-QoL)
Measured: Last 4 weeks before each visit
Change in Dermatology Life Quality Index (DLQI).
A 10-item dermatology-specific health-related quality-of-life measure assessing dermatology symptoms and their impact on various aspects of life, during the course of the study
Measured: Last 7 days before each visit
Urticaria Activity Score for 7 days (UAS7)
Patients willing and able to comply with the UAS7 assessment will be given a paper-based urticaria diary at every site visit and be asked to complete it daily over the week preceding the next site visit. The diary consists of questions to evaluate the severity of their disease, and patients have to assess the severity of their disease, numbers of wheals and severity of itching
Measured: Last 7 days before each visit
Angioedema Activity Score (AAS)
The Angioedema Activitiy Score (AAS) is a validated, easy to use tool to determine disease activity in patients with recurrent angioedema, independent of its underlying causes. The AAS is designed to be used by patients for their daily documentation of swelling episodes including their duration, severity and impact on daily functioning and appearance.
Measured: Last 24 hours before each visit
Urticaria Control Test (UCT)
Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks
Measured: Last 4 weeks before each visit
6-item Work Productivity and Activity Impairment (WPAI) instrument
Respondents are asked questions about work and activity impairment due to health problems
Measured: Last 7 days before each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start24 Dec 2014
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 497 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626221
- Sponsor's protocol ID
- CIGE025EVE01
- Acronym
- AWARE-LACan
- Status last verified
- Dec 2018
- First submitted
- 15 Jan 2015
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study to Collect Real Life Clinical Data on the Impact of Therapy, the Diagnosis and Management of Chronic Urticaria in Patients Refractory to at Least One Course of H1 Antihistamine Therapy
- ClinicalTrials.gov ID
- NCT02626221
- Acronym / sponsor ID
- AWARE-LACan / CIGE025EVE01
- Conditions
- Chronic Urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2014 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 10 Dec 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.
This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks).
In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended.
The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines.
In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study.
The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | – | Other: Non Interventional StudySingle Cohort Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible Latin American Chronic Urticaria adult patients, males and females, with at least one course of H1 antihistamines and is shown to be refractory to this treatment
Key inclusion criteria (2 listed)
- Men or Women at least 18 years of age or older. Patient has medically confirmed diagnosis of chronic urticaria present for more than 2 months.
- Patient has been treated with at least one course of H1 antihistamines and is refractory to this treatment Patient has provided written informed consent allowing the use of their anonymous data for the purposes of the study
Key exclusion criteria (1 listed)
- Patient is currently participating in a clinical trial. Patient is, in the opinion of the treating physician, unlikely to be available for the full duration of the follow-up period of 24 months
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 |
|---|---|---|
| Non Interventional StudyNon Interventional Study | Other | Single |
Primary outcome
Change in CU-Quality of Life Questionnaire Score
Time frame: Last 15 days before each visit
The CU-QoL is a validated instrument with established psychometric properties developed specifically for the assessment of the health burden of CU. The 2013 international CU guideline recommends the use of CU-Q2oL for assessing quality of life impairment and monitoring disease activity.
6 secondary outcomes
Angioedema Quality of Life Questionnaire (AE-QoL)
Time frame: Last 4 weeks before each visit
Change in Dermatology Life Quality Index (DLQI).
Time frame: Last 7 days before each visit
Urticaria Activity Score for 7 days (UAS7)
Time frame: Last 7 days before each visit
Angioedema Activity Score (AAS)
Time frame: Last 24 hours before each visit
Urticaria Control Test (UCT)
Time frame: Last 4 weeks before each visit
6-item Work Productivity and Activity Impairment (WPAI) instrument
Time frame: Last 7 days before each visit
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 7 Dec 2018.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria, run by Novartis Pharmaceuticals at 31 sites in 9 countries.
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 1 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Argentina, Brazil, Colombia, Dominican Republic, Honduras and 4 more countries. 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 CU-Quality of Life Questionnaire Score (time frame: Last 15 days before each visit). 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 7 Dec 2018.