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Asthma ChildhoodNCT07364643

Effectiveness of an Educational Intervention on Asthmatic Children in Inhaled Technique and Adherence.

A study testing Educational Intervention in people with Asthma Childhood, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The goal of this study is to see if a short educational session and demonstration by a nurse can help asthmatic children (6-17 years-old), under hospital control, to manage their asthma better, to use their inhaler correctly, and to know when it should be used. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Asthma Childhood
What is being tested?
Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
No sites listed yet
Study dates
Jan 2026to Jan 2027
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Clinical diagnosis of asthma.
  • Prescribed treatment with inhaled corticosteroid.
  • First-degree relative of the patient.

Who cannot join

  • . Inability to understand Spanish.

About this study

Official title: Assessment of Asthma Management in Children Over 6 Years of Age and Their Caregivers. Implications for the Implementation of the SMART Strategy in Pediatrics.

The goal of this study is to see if a short educational session and demonstration by a nurse can help asthmatic children (6-17 years-old), under hospital control, to manage their asthma better, to use their inhaler correctly, and to know when it should be used.

The main question it aims to answer is how much improvement is reached on asthma self-management. The comparison group is the same group. Researchers will compare results before and after educational intervention.

Read the detailed description

The goal of this study is to see if a short educational session and demonstration by a nurse can help children manage their asthma better, use their inhaler correctly, and know when it should be used.

The study lasts about six months and has two visits:

Visit 1:

Participants will do the usual breathing tests, will show the nurse how to use the inhaler, and answer a few short questionnaires.

Then, the nurse will give some practical education using pictures and demonstrations. She will explain the right way to use the inhaler, to know the device, go over when and why to use inhaled medicine, and teach the participant how to recognize when asthma is getting worse and what can participant do about it.

Visit 2 (after 6 months):

Participants will repeat the same breathing tests and answer questionnaires again, so investigators can see what has changed.

Being tested
Educational Intervention
Keywords
inhaler technique, treatment adherence, asthma self-management, nursing intervention
Medical subject headings
Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionOther

    Educational Intervention:

    The nurse will deliver a brief health education session focused on:

    1. Understanding the treatment. Provide clear information adapted to the patient's level, supported with visual aids.
    2. Distinguishing between maintenance and rescue treatment. Explain the role of each medication with practical examples.
    3. Assessment and correction of inhaler technique. Carry out a step-by-step demonstration and ask the patient to repeat the technique. Use educational materials (placebo devices, videos, diagrams) and reinforce learning with the teach-back method.
    4. Promoting autonomy. Encourage the patient to take part in administering the medication and foster self-management of the device.
    5. Evaluating and improving adherence. Suggest daily routines, reminders, and the use of alarms or mobile apps.
    6. Appropriate use of rescue medication. Involve the patient in decision-making, promote self-observation, and provide a clear action plan.
Study groups in NCT07364643
Study groupRoleWhat they receive
Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultationExperimentalThe included population will undergo an objective assessment with pulmonary function tests and will be given questionnaires to evaluate their knowledge about asthma treatment. Afterwards, they will receive a brief educational intervention and will be scheduled for a follow-up visit at 6 months to reassess pulmonary function parameters and knowledge level.
Receives: Other: Educational Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Correct inhaler technique

    For the qualitative variable "inhaler technique," the Inhaler Technique Questionnaire (InTeQ), validated in pediatrics for the use of pressurized inhalers, will be used. This questionnaire includes 5 items considered critical, with an additional item, "shake the device," added for those using pMDIs.

    The 5 critical steps assessed are: exhale completely before inhalation, close lips firmly, inhale deeply, hold breath afterward, and exhale slowly, which are applicable to both pressurized metered-dose inhalers (pMDI) with a spacer and dry powder inhalers (DPI). The item "device activation" was removed, as it is inherent to the procedure and to facilitate practical applicability.

    Measured: From the nursing intervention until the following 6 months.

Secondary outcomes (1)

  1. Change in Treatment Adherence

    It will be used the only specific questionnaire designed to measure adherence to inhalers, called the Inhaler Adherence Test (IAT). It consists of 10 items to be completed by the patient/caregiver when we want to identify patients with low adherence, and 2 additional items to be completed by the healthcare professional, which are specifically intended to determine the type of unintentional non-adherence.

    Measured: From the nursing intervention until the following 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study startJan 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
428 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364643
Sponsor's protocol ID
IIBSP-EMA-2025-05
Status last verified
Jan 2026
First submitted
22 Sep 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The information will be anonymized by the Principal Investigator (PI)

Publications

  • Frey SM, Fagnano M, Halterman JS. Adolescent Knowledge of When to Use Inhaled Asthma Medications: Implications for Management. J Adolesc Health. 2023 Apr;72(4):623-628. doi: 10.1016/j.jadohealth.2022.10.034. Epub 2022 Dec 15.

    PubMed 36528520

  • Manti S, Licari A, Leonardi S, Marseglia GL. Management of asthma exacerbations in the paediatric population: a systematic review. Eur Respir Rev. 2021 Jul 13;30(161):200367. doi: 10.1183/16000617.0367-2020. Print 2021 Sep 30.

    PubMed 34261742

  • Kosse RC, Koster ES, Kaptein AA, de Vries TW, Bouvy ML. Asthma control and quality of life in adolescents: The role of illness perceptions, medication beliefs, and adherence. J Asthma. 2020 Oct;57(10):1145-1154. doi: 10.1080/02770903.2019.1635153. Epub 2019 Jul 5.

    PubMed 31225980

  • Ciprandi G, Licari A, Castagnoli R, Ciprandi R, Marseglia GL. Asthma control in adolescents: the importance of assessing adherence. Acta Biomed. 2022 Aug 31;93(4):e2022264. doi: 10.23750/abm.v93i4.12448.

    PubMed 36043978

  • Lizano-Barrantes C, Garin O, Mayoral K, Dima AL, Pont A, Caballero-Rabasco MA, Praena-Crespo M, Valdesoiro-Navarrete L, Guerra MT, Bercedo-Sanz A, Ferrer M. Impact of treatment adherence and inhalation technique on asthma outcomes of pediatric patients: a longitudinal study. Front Pharmacol. 2024 Mar 13;15:1340255. doi: 10.3389/fphar.2024.1340255. eCollection 2024.

    PubMed 38549668

  • Basharat S, Jabeen U, Zeeshan F, Bano I, Bari A, Rathore AW. Adherence to asthma treatment and their association with asthma control in children. J Pak Med Assoc. 2018 May;68(5):725-728.

    PubMed 29885170

  • McCrossan P, Shields MD, McElnay JC. Medication Adherence in Children with Asthma. Patient Prefer Adherence. 2024 Mar 5;18:555-564. doi: 10.2147/PPA.S445534. eCollection 2024.

    PubMed 38476591

  • Gonzalez Betlza M, Bruno I, Yemini L, Zuniga C, Bello Pedrosa O. [Impact of a program of health education for the asthmatic child and their families]. Arch Argent Pediatr. 2020 Apr;118(2):145-149. doi: 10.5546/aap.2020.145. Spanish.

    PubMed 32199068

  • Capanoglu M, Dibek Misirlioglu E, Toyran M, Civelek E, Kocabas CN. Evaluation of inhaler technique, adherence to therapy and their effect on disease control among children with asthma using metered dose or dry powder inhalers. J Asthma. 2015 Oct;52(8):838-45. doi: 10.3109/02770903.2015.1028075. Epub 2015 Jun 2.

    PubMed 26037396

  • Almomani BA, Al-Qawasmeh BS, Al-Shatnawi SF, Awad S, Alzoubi SA. Predictors of proper inhaler technique and asthma control in pediatric patients with asthma. Pediatr Pulmonol. 2021 May;56(5):866-874. doi: 10.1002/ppul.25263. Epub 2021 Jan 26.

    PubMed 33497530

  • Tao S, Fan Q, Hariharan VS, Zhi H. Effectiveness of nursing interventions for management of children with bronchial asthma: A systematic review and meta-analysis. Int J Nurs Pract. 2023 Dec;29(6):e13139. doi: 10.1111/ijn.13139. Epub 2023 Mar 6.

    PubMed 36879363

  • Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.

    PubMed 28288272

  • Roche N, Aggarwal B, Boucot I, Mittal L, Martin A, Chrystyn H. The impact of inhaler technique on clinical outcomes in adolescents and adults with asthma: A systematic review. Respir Med. 2022 Oct;202:106949. doi: 10.1016/j.rmed.2022.106949. Epub 2022 Sep 2.

    PubMed 36063773

  • Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.

    PubMed 27060726

  • Price DB, Roman-Rodriguez M, McQueen RB, Bosnic-Anticevich S, Carter V, Gruffydd-Jones K, Haughney J, Henrichsen S, Hutton C, Infantino A, Lavorini F, Law LM, Lisspers K, Papi A, Ryan D, Stallberg B, van der Molen T, Chrystyn H. Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1071-1081.e9. doi: 10.1016/j.jaip.2017.01.004. Epub 2017 Mar 9.

    PubMed 28286157

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention in people with Asthma Childhood, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

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 3 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: opening soon, as of the sponsor's last update on 23 Jan 2026. 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?

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 Correct inhaler technique (time frame: From the nursing intervention until the following 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364643, which also lists 16 linked publications.

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 23 Jan 2026.

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