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

NCT05352126 | Unknown

• 1 other identifier: Prof. Pascal Demoly
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma, Allergic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exacerbation of asthma

  6 months

Study Arms (2)

Puressentiel Purifying spray

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

Other: Biocide

Placebo

PLACEBO COMPARATOR

Saline spray in the similar device as Puressentiel Purifying spray

Other: Biocide

Interventions

Biocide 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; Puressentiel Purifying spray

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Puressentiel: lead

MeSH Terms

Conditions

Asthma

Interventions

Disinfectants

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Pascal Demoly, MD

CONTACT

33467336107; pascal.demoly@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre prospective cross-over, randomised, double-blind placebo-controlled trial

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share