Allergic RhinitisARCTEnfantsNCT03075917
Validation of an Allergic Rhinitis Control Test in Children
A study testing Self Questionnaire in people with Allergic Rhinitis, run by University Hospital, Montpellier at 6 sites 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 5 to 11 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Self Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 6 sitesFrance
- Study dates
- 4 May 2017to 18 Jul 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 5 to 11 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 treatment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Louis Pasteur
Bagnols-sur-Cèze
Maison de santé de Lasalle
Lasalle, 30460
CH de MILLAU
Millau
Centre (Ctre) Medical Ravas - Malbosc
Montpellier, 34080
University hospital of Montpellier
Montpellier, 34295
Hôpital Trousseau,
Paris
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 teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.
- Conditions
- Allergic Rhinitis
- Being tested
- Self Questionnaire
- 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 QuestionnaireOther
self questionnaire for allergic rhinitis control
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | questionnaire for allergic rhinitis control children from 5 to 11 years old who complete a self questionnaire regarding allergic rhinitis control during the consultation and after 15 days Receives: Other: Self Questionnaire |
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
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 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 posted9 Mar 2017
- Study start4 May 2017
- Primary completion18 Jul 2026
- Study completion18 Jul 2026
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
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075917
- Sponsor's protocol ID
- RECHMPL16_0283
- Acronym
- ARCTEnfants
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2017
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Allergic Rhinitis Control Test in Children
- ClinicalTrials.gov ID
- NCT03075917
- Acronym / sponsor ID
- ARCTEnfants / RECHMPL16_0283
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 18 Jul 2026 (actual)
- Study completion
- 18 Jul 2026 (actual)
- First posted
- 9 Mar 2017 (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.
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 teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Self Questionnairequestionnaire for allergic rhinitis control children from 5 to 11 years old who complete a self questionnaire regarding allergic rhinitis control during the consultation and after 15 days |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 5 to 11 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 treatment.
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 Questionnaireself questionnaire for allergic rhinitis control | Other | Experimental |
Primary outcome
Score of the allergic rhinitis control self questionnaire
Time frame: 15 days
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.
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 27 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Questionnaire in people with Allergic Rhinitis, run by University Hospital, Montpellier at 6 sites 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: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Score of the allergic rhinitis control self questionnaire (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 27 Jul 2026.