Asthma, Allergic Clinical Trial
Official title:
Effects 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.
The main objective of this study is to evaluate, in real life, the efficacy of prolonged use (6 months) of Puressentiel Air Purifying Spray with 41 essential oils on the control of allergy-induced asthma in the homes of patients with mild to moderate asthma. This will be performed by evaluating the efficacy of prolonged use (6 months) in the indoor environment on the exacerbation and the symptoms of asthma in patients with mild to moderate asthma. The tolerance of the study patients to spraying in an indoor environment will also be analysed.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04435990 -
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
|
Phase 3 | |
Completed |
NCT03563521 -
Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
|
||
Completed |
NCT02990117 -
ICS Treatment Compliance of Asthma Patients
|
||
Completed |
NCT03468790 -
Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.
|
Phase 3 | |
Recruiting |
NCT04898283 -
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
|
Phase 3 | |
Recruiting |
NCT03455959 -
Lung-Resident Memory Th2 Cells in Asthma
|
N/A | |
Completed |
NCT01104012 -
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
|
N/A | |
Not yet recruiting |
NCT06027073 -
Biologics and Sublingual Immunotherapy
|
Phase 4 | |
Recruiting |
NCT05720325 -
Dupilumab Effects Against Aeroallergen Challenge
|
Phase 2 | |
Completed |
NCT03112577 -
Study of REGN3500 and Dupilumab in Patients With Asthma
|
Phase 1 | |
Recruiting |
NCT04891237 -
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
|
Phase 3 | |
Terminated |
NCT02953106 -
Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis
|
Phase 4 | |
Completed |
NCT06063044 -
Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children
|
||
Completed |
NCT03705325 -
Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
|
N/A | |
Recruiting |
NCT05478824 -
IL13 Signaling in Allergic Asthma
|
||
Withdrawn |
NCT04035109 -
Anakinra as a Rescue Treatment for Allergic Inflammation
|
Phase 1/Phase 2 | |
Suspended |
NCT04109807 -
Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)
|
N/A | |
Recruiting |
NCT03983603 -
Plant Stanol Esters and Preventing Asthma Symptoms
|
N/A | |
Not yet recruiting |
NCT05740748 -
Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
|
Phase 2 |