COVID-19NCT04681079
Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19
An observational study of COVID-19, run by Theravance Biopharma at 1 site in United States.
Trial summary
A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- albuterol sulfate (MDI) and albuterol sulfate (nebulizer)
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 18 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with mild to moderate COVID-19
Who may be able to join
- Willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures
- Willing and able to comply with study-related procedures/assessments
- Adults over 18 years of age
- COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days
Who cannot join
- Subjects currently receiving mechanical ventilation or noninvasive positive-pressure ventilation, or subjects who, in the opinion of the investigator, will require ventilatory support (i.e., mechanical ventilation or noninvasive positive-pressure ventilation) within the next 12 hours Note: Signs of impending need for ventilatory support include pronounced hypoxia despite supplemental oxygen >6 L/min, prolonged respiratory rate (i.e., >30 breaths per minute), signs of respiratory muscle fatigue, or paradoxical diaphragm.
- Presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
- Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol
- Participating in other clinical trials related to COVID-19 thought to interfere with study interpretation (e.g., antivirals or antibodies that might change the viral load over the course of a day; subjects should not receive antibody therapy within 24 hours before the baseline period)
- Active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months
- Pregnant or currently breast feeding, or a positive urine pregnancy dip test performed at baseline (women only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Theravance Biopharma Investigational Site
Kansas City, Kansas, 66160
About this study
Official title: A 2-Period, Crossover Study to Assess the Impact of Nebulizer With Filtered Mouthpiece vs MDI With Spacer on Viral Load in Rooms of Subjects With Mild to Moderate COVID-19
A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19.
Read the detailed description
Observational Study Model = Other [non-treatment; impact on external location (rooms and surfaces)]
Time Perspective = Other [viral load samples taken at various time points after nebulization or MDI administered]
Sampling Method = Non-probability sample [to be described by study team]
- Conditions
- COVID-19
- Being tested
- albuterol sulfate (MDI), albuterol sulfate (nebulizer)
- Keywords
- Nebulizer, MDI, Meter Dosed Inhaler, Filter, Spacer, COVID-19, Coronavirus disease 2019, SARS-CoV-2, Aerosol, Viral transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuterol sulfate (MDI)Drug
albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer
albuterol sulfate (nebulizer)Drug
albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece
| Study group | Role | What they receive |
|---|---|---|
| Crossover Sequence 1 | Subjects randomized to receive commercially available albuterol sulfate via MDI with spacer first, followed by albuterol sulfate via nebulizer with filtered mouthpiece. Receives: Drug: albuterol sulfate (MDI); Drug: albuterol sulfate (nebulizer) | |
| Crossover Sequence 2 | Subjects randomized to receive commercially available albuterol sulfate via nebulizer with filtered mouthpiece first, followed by albuterol sulfate via MDI with spacer. Receives: Drug: albuterol sulfate (MDI); Drug: albuterol sulfate (nebulizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
Change in viral load from baseline at each sample point (room air and surfaces). This outcome measure is listed as exploratory in the protocol.
Measured: Baseline, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start4 May 2021
- Primary completion22 Nov 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681079
- Sponsor's protocol ID
- 0192
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2020
- Last updated
- 28 Jan 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Period, Crossover Study to Assess the Impact of Nebulizer With Filtered Mouthpiece vs MDI With Spacer on Viral Load in Rooms of Subjects With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04681079
- Acronym / sponsor ID
- 0192
- Conditions
- COVID-19
- Keywords
- Nebulizer, MDI, Meter Dosed Inhaler, Filter, Spacer, COVID-19, Coronavirus disease 2019, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 23 Dec 2020 (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.
A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19.
Detailed description
Observational Study Model = Other [non-treatment; impact on external location (rooms and surfaces)]
Time Perspective = Other [viral load samples taken at various time points after nebulization or MDI administered]
Sampling Method = Non-probability sample [to be described by study team]
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover Sequence 1 | – | Drug: albuterol sulfate (MDI), Drug: albuterol sulfate (nebulizer)Subjects randomized to receive commercially available albuterol sulfate via MDI with spacer first, followed by albuterol sulfate via nebulizer with filtered mouthpiece. |
| Crossover Sequence 2 | – | Drug: albuterol sulfate (MDI), Drug: albuterol sulfate (nebulizer)Subjects randomized to receive commercially available albuterol sulfate via nebulizer with filtered mouthpiece first, followed by albuterol sulfate via MDI with spacer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with mild to moderate COVID-19
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures
- Willing and able to comply with study-related procedures/assessments
- Adults over 18 years of age
- COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days
Key exclusion criteria (6 listed)
- Subjects currently receiving mechanical ventilation or noninvasive positive-pressure ventilation, or subjects who, in the opinion of the investigator, will require ventilatory support (i.e., mechanical ventilation or noninvasive positive-pressure ventilation) within the next 12 hours Note: Signs of impending need for ventilatory support include pronounced hypoxia despite supplemental oxygen >6 L/min, prolonged respiratory rate (i.e., >30 breaths per minute), signs of respiratory muscle fatigue, or paradoxical diaphragm.
- Presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
- Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol
- Participating in other clinical trials related to COVID-19 thought to interfere with study interpretation (e.g., antivirals or antibodies that might change the viral load over the course of a day; subjects should not receive antibody therapy within 24 hours before the baseline period)
- Active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months
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 |
|---|---|---|
| albuterol sulfate (MDI)albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer | Drug | Crossover Sequence 1, Crossover Sequence 2 |
| albuterol sulfate (nebulizer)albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece | Drug | Crossover Sequence 1, Crossover Sequence 2 |
Primary outcome
Viral Load
Time frame: Baseline, Day 1
Change in viral load from baseline at each sample point (room air and surfaces). This outcome measure is listed as exploratory in the protocol.
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 28 Jan 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.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Theravance Biopharma at 1 site in United States.
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 28 Jan 2022. 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 United States. 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?
Viral Load (time frame: Baseline, Day 1). 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 Jan 2022.