Towards Participatory Paediatric Asthma Action Plans

NCT04810169 | Completed

• 2 other identifiers: APHP2009372020-A02722-37
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma

Keywords

Action plan; Asthma; Paediatric

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• Improvement of one or more symptoms

  6 months

• Elimination of one or more symptoms

  6 months

• Compliance score for action plan

  6 months

• Overtreatment by families

  6 months

• Undertreatment by families

  6 months

Study Arms (1)

Smart inhaler

Children with smart inhaler

Device: Smart inhaler

Interventions

Smart inhaler DEVICE

* 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

Smart inhaler

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with asthma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants malades

Paris, 75015, France

Location

Related Publications (4)

• 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.

  PMID: 19541064 BACKGROUND

• 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.

  PMID: 28302126 BACKGROUND

• 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.

  PMID: 30914646 BACKGROUND

• 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.

  PMID: 40169179 RESULT

Related Links

• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. (2020)

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David DRUMMOND, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 22, 2021
• Study Start: December 10, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)