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

NCT ID: NCT05352126

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-03-31

Brief 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.

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.

Conditions

Asthma, Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Biocide

Intervention Type: OTHER

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

Saline spray in the similar device as Puressentiel Purifying spray

Group Type: PLACEBO_COMPARATOR

Biocide

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puressentiel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pascal Demoly, MD

Role: CONTACT

pascal.demoly@inserm.fr

33467336107

Other Identifiers

Prof. Pascal Demoly

Identifier Type: -

Identifier Source: org_study_id