Allergic AsthmaNCT06267261
Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber
A study testing KOLMI® surgical face mask (OP-Air) in people with Allergic Asthma and Allergic Rhinitis, run by Alyatec at 1 site in France.
Trial summary
There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Asthma, Allergic Rhinitis
- What is being tested?
- KOLMI® surgical face mask (OP-Air)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 25 Oct 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Subjects who signed the written informed consent,
- Subjects covered by health social identification number,
- Subjects able to understand and complete study-related procedures,
- Subjects reported history of symptomatic birch pollen allergen-triggered asthma (GINA1) with associated allergic rhinitis,
- Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction < 2 mm),
- Positive sIgE tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L),
- Subjects with FEV1 ≥ 70% predicted at screening and before allergen exposure,
- Subjects with at least one drop in FEV1 ≥20% during the 1-hour baseline exposure
- ACT≥ 20,
- Women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.
Main Exclusion Criteria:
- Allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit,
- Ongoing allergen immunotherapy to another allergen,
- History of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy,
- History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion,
- Nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis,
- Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects in ALYATEC Environmental Exposure Chamber
There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.
Read the detailed description
All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.
Allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Being tested
- KOLMI® surgical face mask (OP-Air)
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOLMI® surgical face mask (OP-Air)Device
12 subjects are exposed to birch pollen allergen in ALYATEC EEC while wearing a KOLMI® surgical face mask (OP-Air)
| Study group | Role | What they receive |
|---|---|---|
| Patients with face mask | Experimental | Birch pollen allergen exposure in ALYATEC chamber with face mask Receives: Device: KOLMI® surgical face mask (OP-Air) |
| Patients without face mask | No intervention | Birch pollen allergen exposure in ALYATEC chamber without face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to early asthma response (EAR)
The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC
Measured: 0 to 6 hours
Secondary outcomes (3)
Frequency of EAR and late asthma response (LAR)
The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC
Measured: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Severity of EAR and LAR
The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure
Measured: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Nasal Symptoms
The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS)
Measured: 0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Jun 2021
- Primary completion23 Aug 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyatec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicom
- Responsible party
- Sponsor
- Investigators
- Frédéric de Blay, Pr, Principal investigator, Chest Diseases Department, Strasbourg University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267261
- Sponsor's protocol ID
- KOL-001
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2024
- Last updated
- 30 Jul 2024
- Results posted
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects in ALYATEC Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT06267261
- Acronym / sponsor ID
- KOL-001
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Collaborators
- Medicom
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 20 Feb 2024 (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.
There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.
Detailed description
All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.
Allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with face mask | Experimental | Device: KOLMI® surgical face mask (OP-Air)Birch pollen allergen exposure in ALYATEC chamber with face mask |
| Patients without face mask | No intervention | –Birch pollen allergen exposure in ALYATEC chamber without face mask |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| KOLMI® surgical face mask (OP-Air)12 subjects are exposed to birch pollen allergen in ALYATEC EEC while wearing a KOLMI® surgical face mask (OP-Air) | Device | Patients with face mask |
Primary outcome
Time to early asthma response (EAR)
Time frame: 0 to 6 hours
The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC
3 secondary outcomes
Frequency of EAR and late asthma response (LAR)
Time frame: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Severity of EAR and LAR
Time frame: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Nasal Symptoms
Time frame: 0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Study resultsLink provided by the sponsor.
- 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.
Frédéric de Blay, Pr principal investigator
Chest Diseases Department, Strasbourg University Hospital, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOLMI® surgical face mask (OP-Air) in people with Allergic Asthma and Allergic Rhinitis, run by Alyatec at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to early asthma response (EAR) (time frame: 0 to 6 hours). 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 30 Jul 2024.