Towards Participatory Paediatric Asthma Action Plans (PACAP)

• ClinicalTrials.gov Identifier: NCT04810169
• Recruitment Status: Not yet recruiting
• First Posted: March 22, 2021
• Last Update Posted: November 22, 2021
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment
Asthma	Device: Smart inhaler

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Towards Participatory Paediatric Asthma Action Plans
• Estimated Study Start Date: December 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Smart inhaler; Children with smart inhaler	Device: Smart inhaler; 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

Outcome Measures

Primary Outcome Measures :

1. Mean number of actuations of the emergency treatment in the group "symptom improvement" [ Time Frame: 18 months ]
   Mean number of actuations in asthma attacks asthma attack for which parents think that the emergency treatment has been effective (group "symptom improvement"), for each symptom or symptom association
2. Mean duration between two actuations of the emergency treatment in the group "symptom improvement" [ Time Frame: 18 months ]
   Mean duration between two actuations in asthma attacks for which parents think that the emergency treatment has been effective (group "symptom improvement"), for each symptom or symptom association

Secondary Outcome Measures :

1. Mean number of actuations of the emergency treatment between the groups "symptom improvement" and "no improvement" [ Time Frame: 18 months ]
   Mean number of actuations for each symptom or symptom association, between asthma attack for which parents think that the emergency treatment has been effective (group "symptom improvement"), and asthma attacks for which parents think that the emergency treatment has not been effective (group "no improvement")
2. Mean duration between two actuations of the emergency treatment between the groups "symptom improvement" and "no improvement" [ Time Frame: 18 months ]
   Mean duration between actuations for each symptom or symptom association, between asthma attack for which parents think that the emergency treatment has been effective (group "symptom improvement"), and asthma attacks for which parents think that the emergency treatment has not been effective (group "no improvement")
3. Percentage of asthma attacks treated according to each guideline [ Time Frame: 18 months ]
   Percentage of asthma attacks treated following the GINA guidelines (2 puffs every 10 min), the BTS guidelines (1 puff every 30 seconds with a maximum of 10 puffs), the French guidelines (1 puff/2kg every 20 minutes)
4. Percentage of asthma attacks treated according to the asthma action plan of families [ Time Frame: 18 months ]
   For families with an asthma action plan provided by their physician, the percentage of asthma attacks treated by parents according to their asthma action plan will be presented, providing an evaluation of the adherence of families to their asthma action plan.
5. Overtreatment by families [ Time Frame: 18 months ]
   For families with an asthma action plan provided by their physician, estimate the percentage of asthma attacks treated with ≥ 150% of the number of puffs prescribed by their physician (for example, the physician prescribed 5 puffs, the child was provided 8 puffs or more).
6. Undertreatment by families [ Time Frame: 18 months ]
   For families with an asthma action plan provided by their physician, estimate the percentage of asthma attacks treated with ≤ 50% of the number of puffs prescribed by their physician (for example, the physician prescribed 5 puffs, the child was provided 2 puffs or less

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children with asthma

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: David DRUMMOND, MD, PhD; +33 1 44 49 48 48; david.drummond@aphp.fr

Contact: Sandra COLAS; +33 1 71 19 64 32; sandra.colas@aphp.fr

Locations

France

Hôpital Necker-Enfants malades

Paris, France, 75015

Contact: David DRUMMOND, MD, PhD +33 1 44 49 48 48

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: David DRUMMOND, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

Additional Information:

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

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. French.

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. Review.

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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04810169
• Other Study ID Numbers: APHP200937; 2020-A02722-37 ( Other Identifier: ID-RCB )
• First Posted: March 22, 2021
• Last Update Posted: November 22, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Action plan; Asthma; Paediatric

Additional relevant MeSH terms:

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