HealthyQUELLENCT04771585
Quantification of Exhaled Particles to Identify Airborne Transmission Risks of COVID-19
A study testing Community Mask, Surgical Mask and FFP2 respirator in people with Healthy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Community Mask, Surgical Mask and FFP2 respirator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2021to 20 Aug 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Healthy male and female subjects, aged 18-80 years.
- Body mass index between 18 and 35 kg/m2.
- FEV1 ≥ 80% predicted.
Who cannot join
- Any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- History of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. In case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. Subjects must be asymptomatic for at least 3 days. Re-screening is allowed should the time window be exceeded.
- History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis.
- History of latex allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2
In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.
- Conditions
- Healthy
- Being tested
- Community Mask, Surgical Mask, FFP2 respirator, FFP3 respirator
- Keywords
- Aerosols, Exhaled particles, Face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community MaskOther
Fabric mask, no medical device
Surgical MaskOther
Medical face mask (personal protective equipment), CE-certified
FFP2 respiratorOther
Filtering Face Piece with no less than 94% filtering capacity, CE-certified
FFP3 respiratorOther
Filtering Face Piece with no less than 99% filtering capacity, CE-certified
| Study group | Role | What they receive |
|---|---|---|
| Study Part A | No intervention | Aerosol number and size spectrum characterization of 30 subjects, stratified by age groups, including 10 professional singers. Subjects will be examined twice within 14 days to assess reproducibility of aerosol emission. |
| Study Part B | Experimental | From the 30 subjects of Part A, the 10 highest-emitting subjects will be assessed a third time, wearing four different classes of face masks consecutively with increasing aerosol filtering capacity. Receives: Other: Community Mask; Other: Surgical Mask; Other: FFP2 respirator; Other: FFP3 respirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the emitted small particle fraction between various respiratory activities.
Change of particle number per time unit between tidal breathing and various respiratory activities.
Measured: Day 1, Day 2 to 14
To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.
Change of particle number per time unit between tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects.
Measured: After completion of Study part A (approximately 3 months)
Secondary outcomes (3)
To assess the emitted particle size distribution of various respiratory activities.
Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities.
Measured: Day 1, Day 2 to 14
To assess the reproducibility of exhaled particle quantification.
Compare results for particle number per time unit and particle size spectrum from visit 1 and 2.
Measured: Day 2 to 14
To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.
Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects.
Measured: After completion of Study part A (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start29 Mar 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In part A of the study, aerosol emission of subjects will be characterized. From this population, the 10 highest-emitting subjects will enter part B of the study to investigate the effect of face masks on aerosol emission down to the submicron range.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771585
- Sponsor's protocol ID
- 20-14 QUELLE
- Acronym
- QUELLE
- Status last verified
- Aug 2021
- First submitted
- 26 Jan 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz K, Struss N, Banari L, Hohlfeld JM. Quantifying Exhaled Particles in Healthy Humans During Various Respiratory Activities Under Realistic Conditions. J Aerosol Med Pulm Drug Deliv. 2024 Apr;37(2):51-63. doi: 10.1089/jamp.2022.0076. Epub 2024 Jan 29.
PubMed 38285475
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2
- ClinicalTrials.gov ID
- NCT04771585
- Acronym / sponsor ID
- QUELLE / 20-14 QUELLE
- Conditions
- Healthy
- Keywords
- Aerosols, Exhaled particles, Face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 25 Feb 2021 (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.
In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In part A of the study, aerosol emission of subjects will be characterized. From this population, the 10 highest-emitting subjects will enter part B of the study to investigate the effect of face masks on aerosol emission down to the submicron range.
| Arm | Type | Receives |
|---|---|---|
| Study Part A | No intervention | –Aerosol number and size spectrum characterization of 30 subjects, stratified by age groups, including 10 professional singers. Subjects will be examined twice within 14 days to assess reproducibility of aerosol emission. |
| Study Part B | Experimental | Other: Community Mask, Other: Surgical Mask, Other: FFP2 respirator, Other: FFP3 respiratorFrom the 30 subjects of Part A, the 10 highest-emitting subjects will be assessed a third time, wearing four different classes of face masks consecutively with increasing aerosol filtering capacity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to give written informed consent.
- Healthy male and female subjects, aged 18-80 years.
- Body mass index between 18 and 35 kg/m2.
- FEV1 ≥ 80% predicted.
Key exclusion criteria (6 listed)
- Any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- History of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. In case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. Subjects must be asymptomatic for at least 3 days. Re-screening is allowed should the time window be exceeded.
- History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis.
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 |
|---|---|---|
| Community MaskFabric mask, no medical device | Other | Study Part B |
| Surgical MaskMedical face mask (personal protective equipment), CE-certified | Other | Study Part B |
| FFP2 respiratorFiltering Face Piece with no less than 94% filtering capacity, CE-certified | Other | Study Part B |
| FFP3 respiratorFiltering Face Piece with no less than 99% filtering capacity, CE-certified | Other | Study Part B |
Primary outcome
To compare the emitted small particle fraction between various respiratory activities.
Time frame: Day 1, Day 2 to 14
Change of particle number per time unit between tidal breathing and various respiratory activities.
To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.
Time frame: After completion of Study part A (approximately 3 months)
Change of particle number per time unit between tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects.
3 secondary outcomes
To assess the emitted particle size distribution of various respiratory activities.
Time frame: Day 1, Day 2 to 14
To assess the reproducibility of exhaled particle quantification.
Time frame: Day 2 to 14
To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.
Time frame: After completion of Study part A (approximately 3 months)
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 26 Aug 2021.
- Derived from this study: PubMed 38285475Schwarz K, Struss N, Banari L, Hohlfeld JM. Quantifying Exhaled Particles in Healthy Humans During Various Respiratory Activities Under Realistic Conditions. J Aerosol Med Pulm Drug Deliv. 2024 Apr;37(2):51-63. doi: 10.1089/jamp.2022.0076. Epub 2024 Jan 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Mask, Surgical Mask and FFP2 respirator in people with Healthy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Aug 2021. 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 Germany. 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?
To compare the emitted small particle fraction between various respiratory activities. (time frame: Day 1, Day 2 to 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771585, which also lists 1 linked publication.
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 26 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.