Asthma, AllergicPSIndACNCT05352126
Effects of Puressentiel Purifying Spray on Asthma Control in Patients With Mild to Moderate Allergy-induced Asthma.
A study testing Biocide in people with Asthma, Allergic, run by Puressentiel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Allergic
- What is being tested?
- Biocide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Biocide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiocideOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Biocide |
| Placebo | Placebo comparator | Saline spray in the similar device as Puressentiel Purifying spray Receives: Other: Biocide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Exacerbation of asthma
Number of exacerbations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicentre prospective cross-over, randomised, double-blind placebo-controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puressentiel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352126
- Sponsor's protocol ID
- Prof. Pascal Demoly
- Acronym
- PSIndAC
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05352126
- Acronym / sponsor ID
- PSIndAC / Prof. Pascal Demoly
- Conditions
- Asthma, Allergic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- PuressentielIndustry (pharma, biotech, devices)
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Multicentre prospective cross-over, randomised, double-blind placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Puressentiel Purifying spray | Experimental | Other: BiocidePuressentiel 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 |
| Placebo | Placebo comparator | Other: BiocideSaline spray in the similar device as Puressentiel Purifying spray |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • 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)
Key exclusion criteria (7 listed)
- • Patients who have had a viral infection in the month prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiocideThe 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). | Other | Placebo, Puressentiel Purifying spray |
Primary outcome
Asthma control
Time frame: 6 months
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
1 secondary outcome
Exacerbation of asthma
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Biocide in people with Asthma, Allergic, run by Puressentiel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Demoly, MD (33467336107, pascal.demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.