Effects of Puressentiel Purifying Spray on Asthma Control in Patients With Mild to Moderate Allergy-induced Asthma. (PSIndAC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma, Allergic
• Intervention / Treatment: Other: Biocide

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal Demoly, MD; Phone Number: 33467336107; Email: pascal.demoly@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Puressentiel Purifying spray; Puressentiel Air Purifying Spray with 41 essential oils Capacity: 200 ml BIOCIDE Product type 2: Disinfectants used in the private and public health sector Composition: Ethanol (CAS no. 64-17-5) 75% m/m and 41 essential oils	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).
Placebo Comparator: Placebo; Saline spray in the similar device as Puressentiel Purifying spray	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation of asthma	Number of exacerbations	6 months

Collaborators and Investigators

• Sponsor: Puressentiel

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: Prof. Pascal Demoly

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No