Chronic UrticariaAWARENCT02435238
AWARE - Chronic Urticaria
An observational study of Chronic Urticaria, run by Novartis Pharmaceuticals at 21 sites in United Kingdom.
Trial summary
Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Urticaria
- How many people
- 180 participants
- Where
- 21 sitesUnited Kingdom
- Study dates
- 3 Sep 2014to 27 Sep 2017
- 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: Chronic Urticaria Patients
Who may be able to join
- Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.
- Subject must be refactory to at least one H1 antihistamine
Who cannot join
- Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.
- Subjects taking must not take part in any other concurrent urticarial study.
- -
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United Kingdom21 sites
Novartis Investigative Site
Belfast, BT12 6BA
Novartis Investigative Site
Belfast, BT9 7AB
Novartis Investigative Site
Cardiff, CF14 4XW
Novartis Investigative Site
Chester, CH2 1UL
Novartis Investigative Site
Coventry, Warwickshire, CV2 2DX
Novartis Investigative Site
Darlington, Durham, DL3 6HX
Novartis Investigative Site
Durham, DH1 6TW
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
Kent, CT9 4AN
Novartis Investigative Site
Leeds, LS9 7PN
Novartis Investigative Site
Leicester, LE1 5WW
Novartis Investigative Site
Leytonstone, London, E11 1NR
Novartis Investigative Site
Liverpool, L14 3PE
Novartis Investigative Site
London, SE18 4QH
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Manchester, M23 9LT
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Plymouth, Devon, PL6 8DH
Novartis Investigative Site
Poole, BH15 2JB
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Sheffield, S5 7AU
About this study
Official title: AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation
Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.
- Conditions
- Chronic Urticaria
- Medical subject headings
- Chronic Urticaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring responses to PROs from patients on different treatments
Measuring quality of life, work productivity and changes in disease for patients on different treatment.
Measured: 24 months
Secondary outcomes (11)
To record use of clinical resources
Measuring how often clinical resources (hospitalisations, frequency of visits) are used
Measured: 24 months
Previous, current and future medication
Recording medication use throughout the 24 months
Measured: 24 months
The disease burden of chronic urticaria
The "disease burden" (including impact on sleep and work productivity)
Measured: 24 months
Rates of spontaneous remission
Measured: 24 months
Treatment algorithms and trends
Measuring treatment algorithms and trends during the study course (including therapy adjustments and duration of use of each substance class)
Measured: 24 months
Co-morbidities of refractory CU patients
Measured: 24 months
first onset of chronic urticaria
Time of first onset of the disease and number physicians consulted
Measured: 24 months
Number of patients with angiodema
Measured: 24 months
Number of angioedema episodes during the observational phase
Measured: 24 months
Prevalence of inducible urticaria
The number of patients in the study population that are diagnosed with inducible urticaria.
Measured: 24 months
Diagnosis of CSU
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start3 Sep 2014
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435238
- Sponsor's protocol ID
- CIGE025EGB01
- Acronym
- AWARE
- Status last verified
- Feb 2018
- First submitted
- 2 Dec 2014
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation
- ClinicalTrials.gov ID
- NCT02435238
- Acronym / sponsor ID
- AWARE / CIGE025EGB01
- Conditions
- Chronic Urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 6 May 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.
Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Urticaria Patients
Key inclusion criteria (2 listed)
- Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.
- Subject must be refactory to at least one H1 antihistamine
Key exclusion criteria (3 listed)
- Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.
- Subjects taking must not take part in any other concurrent urticarial study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring responses to PROs from patients on different treatments
Time frame: 24 months
Measuring quality of life, work productivity and changes in disease for patients on different treatment.
11 secondary outcomes
To record use of clinical resources
Time frame: 24 months
Previous, current and future medication
Time frame: 24 months
The disease burden of chronic urticaria
Time frame: 24 months
Rates of spontaneous remission
Time frame: 24 months
Treatment algorithms and trends
Time frame: 24 months
Co-morbidities of refractory CU patients
Time frame: 24 months
first onset of chronic urticaria
Time frame: 24 months
Number of patients with angiodema
Time frame: 24 months
Number of angioedema episodes during the observational phase
Time frame: 24 months
Prevalence of inducible urticaria
Time frame: 24 months
Diagnosis of CSU
Time frame: 24 months
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 15 Feb 2018.
Related trials for Chronic Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Chronic Spontaneous Urticaria
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.
21 sites in 1 country: 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 21 sites in United Kingdom.
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 3 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom. 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?
Measuring responses to PROs from patients on different treatments (time frame: 24 months). 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 15 Feb 2018.