Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04810169
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Towards Participatory Paediatric Asthma Action Plans
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Towards Participatory Paediatric Asthma Action Plans
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACAP
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A02722-37 | OTHER | ID-RCB | View |