Suspended

PSIndACEffects 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.

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What is being tested

Biocide

Other
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorPuressentiel
Study ContactPascal Demoly, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleEffects 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.
NCT05352126
Principal SponsorPuressentiel
Study ContactPascal Demoly, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Saline spray in the similar device as Puressentiel Purifying spray

Group II

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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