Asthma, Allergic Clinical Trial
— PSIndACOfficial 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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Puressentiel |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma control | The primary endpoint of this study is the Asthma Control Test (ACT), which is assessed after 6 months of exposure and compared to 6 months without exposure, with the patient being his or her own control. A difference of 2 points questionnaire ranging from 5 to 25 is considered clinically significant | 6 months | |
Secondary | Exacerbation of asthma | Number of exacerbations | 6 months |
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