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AsthmaPACAPNCT04810169

Towards Participatory Paediatric Asthma Action Plans

An observational study of Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Asthma is the most common chronic disease in children. The management of asthma attacks at home is based on asthma action plans that are very heterogeneous and reflect the diversity of recommendations on this subject. Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Asthma
What is being tested?
Smart inhaler
Type of treatment
Medical device
How many people
120 participants
Where
1 siteFrance
Study dates
10 Dec 2021to 26 Jul 2023
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 3 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with asthma

Who may be able to join

  • Parent of 18 years or more
  • Parent with a smartphone compatible with a smart inhaler
  • Parent with child who :
  • is 3 years to 11 years 11 months old
  • has physician-diagnosed asthma diagnosis
  • has a prescription of emergency treatment in case of asthma symptom
  • Non-opposition of the legal guardian

Who cannot join

  • Refuse to participate at the study
  • Difficulty reading and/or understanding French language
  • Technical problem (malfunction) with the smart inhalers and/or the associated mobile application during the initial test with the parent's smartphone

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Necker-Enfants malades

    Paris, 75015

Other trials in France

About this study

Asthma is the most common chronic disease in children. The management of asthma attacks at home is based on asthma action plans that are very heterogeneous and reflect the diversity of recommendations on this subject. The purpose of this study is to observe using smartinhalers how children and their families use their emergency treatment at home in case of asthma symptoms and asthma attacks, to allow building new recommendations based not only on the literature, but also on real-world data.

Read the detailed description

Asthma is the most common chronic disease in children. Asthma exacerbations are responsible for many unscheduled consultations by paediatricians and general practitioners, numerous emergency room visits and frequent hospitalizations

Asthma action plans are documents given to families and schools to give the actions to be taken in the event of an asthma attack occurring in the family or school environment. They are recommended by all learned societies, because, combined with patient education and regular consultations, they reduce the need for unscheduled care.

The main drug in the action plan is the emergency treatment, i.e. a short-acting bronchodilator (SABA). However, the doses of SABA to be used vary widely depending on the recommendations. For children up to 5 years of age, the international board of the Global Initiative for Asthma (GINA) suggests limiting the home dose to 2 puffs of 100μg every 20 minutes, to be repeated twice before consulting a physician if there is no improvement. This dose is increased to 4-10 puffs every 20 minutes in children 6 years and older. The British Thoracic Society in the United Kingdom advises administering salbutamol puffs one at a time, 30 to 60 seconds apart, until symptoms improve, with a maximum of 10 puffs. In France, the Groupe de Recherche sur les Avancées en PneumoPédiatrie (GRAPP) recommends to administer higher doses of salbutamol at home, up to one puff per 2 kg of weight, with a maximum of 10 to 15 puffs, to be repeated every 20 minutes for one hour, before giving oral corticosteroids. These very heterogeneous protocols reflect the diversity of doses proposed in the literature, and the paucity of clinical research data that makes it impossible to determine whether one approach is better than another. A study that looked at the goals of parents of children with asthma highlighted that this heterogeneity of practices is a source of stress for families: "I would like one plan and not ten" explained one parent; "I would like a plan that doesn't change all the time" reported another.

Harmonization of practices is necessary in order to provide families and school physicians nurses with a consistent approach..

The aim of this study is therefore to observe, using inhalers connected to salbutamol inhalers (smart inhalers), how families manage an asthma exacerbation at home, and to integrate these data into the establishment of future recommendations.

Conditions
Asthma
Being tested
Smart inhaler
Keywords
Action plan, Asthma, Paediatric
Medical subject headings
Asthma

What participants receive

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

  • Smart inhalerDevice

    • Automatic record (number of actuations and their timing) of the use of the emergency treatment through the smart inhaler
    • Questionnaire sent to the parents at each use of the smart inhaler to get information regarding the reason of use and the efficacy of the treatment given
Study groups in NCT04810169
Study groupRoleWhat they receive
Smart inhalerChildren with smart inhaler
Receives: Device: Smart inhaler

What is being measured

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

  1. Mean number of emergency-treatments administered in the first two hours of management

    Mean number of emergency-treatments administered in the first two hours of management, depending on the symptoms initially presented by the child (cough, wheezing, dyspnea, or respiratory distress) or an association of symptoms, which led to the disappearance of the symptom(s) that prompted the initiation of salbutamol.

    Measured: 6 months

Secondary outcomes (5)

  1. Improvement of one or more symptoms

    Improvement of the symptom(s), defined in a binary manner as an improvement reported by parents on the mobile application within 24 hours of the onset of the symptom(s).

    Measured: 6 months

  2. Elimination of one or more symptoms

    Elimination of one or more symptoms defined in a binary manner (success/failure) by not using salbutamol for an asthmatic symptom within 24 hours of the onset of the symptom or symptoms.

    Measured: 6 months

  3. Compliance score for action plan

    taking into account the number of salbutamol puffs administered compared to the recommended number of salbutamol puffs, the duration between salbutamol puffs compared to the recommended duration, and the sequence of actions performed (including corticosteroids and use of the healthcare system) compared to the recommended sequence of actions - This score will be calculated as follows: (Number of expected actions on the action plan and according to the evolution of symptoms - Number of actions recorded by the smartinhalers and on the research application) / number of expected actions * 100.

    Measured: 6 months

  4. Overtreatment by families

    Family overuse of salbutamol, defined as ((number of puffs recorded - number of puffs expected)/(number of puffs expected) * 100) strictly greater than 50%.

    Measured: 6 months

  5. Undertreatment by families

    Under-use of salbutamol by families, defined as ((number of puffs recorded - number of puffs expected)/(number of puffs expected) * 100) strictly less than -50%.

    Measured: 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 posted22 Mar 2021
  2. Study start10 Dec 2021
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810169
Sponsor's protocol ID
APHP200937
Other IDs
2020-A02722-37
Acronym
PACAP
Status last verified
Nov 2025
First submitted
8 Mar 2021
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marguet C, Michelet I, Couderc L, Lubrano M. [Management of acute asthma exacerbation in childhood: French recommendations]. Arch Pediatr. 2009 Jun;16(6):505-7. doi: 10.1016/S0929-693X(09)74046-1. No abstract available. French.

    PubMed 19541064

  • Pinnock H, Parke HL, Panagioti M, Daines L, Pearce G, Epiphaniou E, Bower P, Sheikh A, Griffiths CJ, Taylor SJ; PRISMS and RECURSIVE groups. Systematic meta-review of supported self-management for asthma: a healthcare perspective. BMC Med. 2017 Mar 17;15(1):64. doi: 10.1186/s12916-017-0823-7.

    PubMed 28302126

  • Heidi M, Emily K, Benjamin H, Michael C, Robert K, Mitch B, Chris G, Mando W, Andrew B. Patient reported outcomes for preschool children with recurrent wheeze. NPJ Prim Care Respir Med. 2019 Mar 26;29(1):7. doi: 10.1038/s41533-019-0120-3.

    PubMed 30914646

  • Gonsard A, Giovannini-Chami L, Cros P, Masson A, Menetrey C, Mordacq C, Cisterne C, Personnic J, Roy C, Poirault C, Abou Taam R, Hadchouel A, Pirojoc A, Delacourt C, Drummond D. Home use of short-acting beta agonists by children with asthma: a multicentre digital prospective study. Arch Dis Child. 2025 Aug 18;110(9):701-705. doi: 10.1136/archdischild-2024-327447.

    PubMed 40169179

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Assistance Publique - Hôpitaux de Paris 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 7 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 1 Dec 2025. 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?

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?

Mean number of emergency-treatments administered in the first two hours of management (time frame: 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 NCT04810169, which also lists 4 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 1 Dec 2025.

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