Allergic RhinitisARCTadoNCT02818153
Validation of an Allergic Rhinitis Control Test in Teenagers
A study of Allergic Rhinitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Allergic Rhinitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jun 2017
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis
- parents formulated their study participation agreement by signing the consent form.
Who cannot join
- Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.
Trial locations and contacts
1 site in 1 country.
Anca Chiriac, MD contact
France1 site
University hospital of Montpellier
Montpellier, 34295
Pascal Demoly, +33 467336107, pascal.demoly@inserm.fr
About this study
Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents aged 12 to 17 years old and lacked power.
In this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in adolescents 12 to 17 years inclusive.
- Conditions
- Allergic Rhinitis
- Being tested
- Self questionnaire for allergic rhinitis control
- Keywords
- Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self questionnaire for allergic rhinitis controlOther
| Study group | Role | What they receive |
|---|---|---|
| questionnaire for allergic rhinitis control | Experimental | Teenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days Receives: Other: Self questionnaire for allergic rhinitis control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818153
- Sponsor's protocol ID
- 9614
- Acronym
- ARCTado
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Allergic Rhinitis Control Test in Teenagers
- ClinicalTrials.gov ID
- NCT02818153
- Acronym / sponsor ID
- ARCTado / 9614
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Jun 2016 (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.
Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents aged 12 to 17 years old and lacked power.
In this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in adolescents 12 to 17 years inclusive.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire for allergic rhinitis control | Experimental | Other: Self questionnaire for allergic rhinitis controlTeenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis
- parents formulated their study participation agreement by signing the consent form.
Key exclusion criteria (1 listed)
- Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.
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 |
|---|---|---|
| Self questionnaire for allergic rhinitis control | Other | questionnaire for allergic rhinitis control |
Primary outcome
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Anca Chiriac, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Allergic Rhinitis, run by University Hospital, Montpellier 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 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: status not confirmed, as of the sponsor's last update on 29 Jun 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Demoly, Professor (+334 67 33 61 27, pascal.demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old. (time frame: 15 days). 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 29 Jun 2016.