PSIndACEffects of Repeated Sprays of an Air Purifying Spray Containing Essential Oils in an Indoor Environment on Asthma Control in Patients With Mild to Moderate Allergy-induced Asthma.
Biocide
Asthme+6
+ Maladies bronchiques
+ Hypersensibilité
Étude de prévention
Résumé
Date de début de l'étude : 1 mai 2022
Date à laquelle le premier participant a commencé l'étude.At the inclusion visit (V1), the number of exacerbations requiring oral corticosteroids, and asthma treatments (base and rescue medication) during the previous 12 months are collected. An Asthma Control Test (ACT) for self-assessment is given to the patient. This questionnaire (Appendix 1) contains 5 questions related to asthma symptoms and their frequency as well as the rescue medication used in the previous 4 weeks. The ACT score ranges from 5 (most badly controlled) to 25 (fully controlled asthma). The threshold for controlled asthma is 20, with a lower score indicating uncontrolled asthma. (14). Vials of Puressentiel Air Purifying Spray with 41 essential oils or weighed identical placebo bottles are given to the patient according to the randomisation period that he/she has been assigned to. The patient is asked to spray in 2 corners of the bedroom (at bedtime (2/D) for 6 months). A telephone visit will be carried out by the CRA of the study at 3 months (see telephone visit). At the end of the 6 months, the subject is reviewed (V2) and will bring back the used spray bottles which will be weighed to assess compliance. In a second Asthma Control Test (ACT), the number of exacerbations, during the 6 months of use of Puressentiel Air Purifying Spray with 41 essential oils or the placebo is collected. Bottles of placebo air spray or Puressentiel Air Purifying Spray with 41 essential oils are given to the patient according to the randomisation period that he/she has been assigned to during the first visit (V1). The patient is seen again 6 months later (V3), during which time he/she will use the placebo spray or Puressentiel Air Purifier Spray with 41 essential oils, one spray in 2 corners of the bedroom (i.e. 2 sprays in total) in the evening (2/D). A second Asthma Control Test (ACT) is performed and the number of exacerbations over the 6 months is collected. A telephone visit will be carried out by the CRA of the study at 9 months (see telephone visit). If the patient has been randomised to receive the placebo spray during the first six-month period, he/she will use Puressentiel Air Purifying Spray with 41 essential oils during the second six-month period.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.80 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * • Mild to moderate asthma patients with or without rhinitis who were diagnosed with asthma at least one year beforehand. At least partially controlled (16≥ACT≥23) * Patients who are allergic to one allergen per year and/or season (proof of prick tests or specific IgE). * Patients who are over 18 years old. * Patients who have read and signed the informed consent form * Patients who are affiliated to the social security regime Exclusion Criteria: * • Patients who have had a viral infection in the month prior to inclusion * Patients with uncontrolled asthma. * Pregnant or breastfeeding women. * People with a history of seizure disorders, or epilepsy * People with allergies to any of the components of the product * Patients with comprehension difficulties * Patients who cannot be monitored throughout the entire period
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
PlaceboGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires