Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05352126
Other study ID # Prof. Pascal Demoly
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date March 2024

Study information

Verified date April 2022
Source Puressentiel
Contact Pascal Demoly, MD
Phone 33467336107
Email pascal.demoly@inserm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biocide
The product being researched, which is a biocide solution in a spray for atmospheric use without a propellant, will be sprayed in the bedroom of each patient at a rate of 2 sprays per day in the evening (half an hour before going to bed).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Puressentiel

Outcome

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
See also
  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
Suspended NCT04109807 - Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ) N/A
Withdrawn NCT04035109 - Anakinra as a Rescue Treatment for Allergic Inflammation Phase 1/Phase 2
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