Asthma in ChildrenQASNCT06844266
Accuracy of the Association Between the "PA-R" and "ACT" Questionnaires in Asthmatic Pediatric Patients
A study testing Administration of the ACT + PA-R questionnaires and ACT questionnaire in people with Asthma in Children, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
A patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. International guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Administration of the ACT + PA-R questionnaires and ACT questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Correctly diagnosed asthma;
- Age between 6 and 15 years;
- Understanding and signing of the informed consent by the parent/guardian;
- Understanding and signing of the assent by the minor.
Who cannot join
- Inability to correctly perform spirometry;
- Inability to correctly perform the exercise test;
- Unwillingness to sign the informed consent by the parent/guardian;
- Unwillingness to sign the assent by the minor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Accuracy of the Association Between the "Physical Activity-Rating" and "Asthma Control Test" Questionnaires in the Anamnestic Evaluation of Asthma Symptom Control in Pediatric Patients
A patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. International guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. On average, follow-up visits for a child with asthma treated with maintenance pharmacological therapy should be every 3 months. This period is often challenging to meet in clinical practice because of long waiting lists. An alternative solution could involve the use of structured questionnaires that the patient should fill out on their own (if aged 12 or older) or with the help of parents (if younger than 12). A similar solution is also suggested by international asthma guidelines. The doctor, upon receiving the questionnaire, for example through email, could make the appropriate management decisions and communicate them to the patient, again through email. For remote use, the test should have optimal sensitivity and specificity, otherwise, there is a risk of either underestimating or overestimating the need for adjustments to the maintenance therapy. The most commonly used is the Asthma Control Test (ACT), which did non demonstrate an elevated sensibility and specificity as revealed by different studies. Tripoli et al., for example, reported that 22% of children aged 12 or older with an ACT score = 25 have asthma and a fall in FEV1 >12% after physical exertion. Considering the information above, we considered combining the ACT with the Physical Activity-Rating (PA-R), a validated questionnaire for measuring the level of physical activity. It is possible that one of the issues lies in the lack of quantification of the patient's physical activity level when administering the ACT. Through an interventional study, our intention is to assess the diagnostic accuracy of the ACT + PA-R combination (test under experimentation) compared to ACT (traditional test) and compared to reference standard (spirometry before and after exertion). The goal of the study is to evaluate whether the combination of a high score in both the PA-R (>7) and ACT (>21) can accurately identify patients with well-controlled asthma, i.e., those with normal spirometry after physical exertion.
- Conditions
- Asthma in Children
- Being tested
- Administration of the ACT + PA-R questionnaires, ACT questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of the ACT + PA-R questionnairesProcedure or surgery
The "ACT + PA-R" questionnaires will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion.
ACT questionnaireProcedure or surgery
The "ACT" questionnaire will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Control Test (ACT) + PA-R | Experimental | Association of "ACT + PA-R" questionnaires Receives: Procedure: Administration of the ACT + PA-R questionnaires |
| Asthma Control Test (ACT) | Active comparator | ACT questionnaire Receives: Procedure: ACT questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R)
One group of patients will be dministered the ACT test and one group the ACT + PAR test to compare the reliability between the two test and the reference standard (spirometry before and after physical exertion).
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 posted25 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Miceli Sopo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844266
- Sponsor's protocol ID
- 7190
- Acronym
- QAS
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Accuracy of the Association Between the "Physical Activity-Rating" and "Asthma Control Test" Questionnaires in the Anamnestic Evaluation of Asthma Symptom Control in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06844266
- Acronym / sponsor ID
- QAS / 7190
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
A patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. International guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. On average, follow-up visits for a child with asthma treated with maintenance pharmacological therapy should be every 3 months. This period is often challenging to meet in clinical practice because of long waiting lists. An alternative solution could involve the use of structured questionnaires that the patient should fill out on their own (if aged 12 or older) or with the help of parents (if younger than 12). A similar solution is also suggested by international asthma guidelines. The doctor, upon receiving the questionnaire, for example through email, could make the appropriate management decisions and communicate them to the patient, again through email. For remote use, the test should have optimal sensitivity and specificity, otherwise, there is a risk of either underestimating or overestimating the need for adjustments to the maintenance therapy. The most commonly used is the Asthma Control Test (ACT), which did non demonstrate an elevated sensibility and specificity as revealed by different studies. Tripoli et al., for example, reported that 22% of children aged 12 or older with an ACT score = 25 have asthma and a fall in FEV1 >12% after physical exertion. Considering the information above, we considered combining the ACT with the Physical Activity-Rating (PA-R), a validated questionnaire for measuring the level of physical activity. It is possible that one of the issues lies in the lack of quantification of the patient's physical activity level when administering the ACT. Through an interventional study, our intention is to assess the diagnostic accuracy of the ACT + PA-R combination (test under experimentation) compared to ACT (traditional test) and compared to reference standard (spirometry before and after exertion). The goal of the study is to evaluate whether the combination of a high score in both the PA-R (>7) and ACT (>21) can accurately identify patients with well-controlled asthma, i.e., those with normal spirometry after physical exertion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Control Test (ACT) + PA-R | Experimental | Procedure: Administration of the ACT + PA-R questionnairesAssociation of "ACT + PA-R" questionnaires |
| Asthma Control Test (ACT) | Active comparator | Procedure: ACT questionnaireACT questionnaire |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Correctly diagnosed asthma;
- Age between 6 and 15 years;
- Understanding and signing of the informed consent by the parent/guardian;
- Understanding and signing of the assent by the minor.
Key exclusion criteria (4 listed)
- Inability to correctly perform spirometry;
- Inability to correctly perform the exercise test;
- Unwillingness to sign the informed consent by the parent/guardian;
- Unwillingness to sign the assent by the minor.
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 |
|---|---|---|
| Administration of the ACT + PA-R questionnairesThe "ACT + PA-R" questionnaires will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion. | Procedure or surgery | Asthma Control Test (ACT) + PA-R |
| ACT questionnaireThe "ACT" questionnaire will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion. | Procedure or surgery | Asthma Control Test (ACT) |
Primary outcome
Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R)
Time frame: 24 months
One group of patients will be dministered the ACT test and one group the ACT + PAR test to compare the reliability between the two test and the reference standard (spirometry before and after physical exertion).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
Stefano Miceli Sopo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Administration of the ACT + PA-R questionnaires and ACT questionnaire in people with Asthma in Children, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Miceli Sopo (+390630155701, Stefano.MiceliSopo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R) (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 25 Feb 2025.