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.
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]
Drug: albuterol sulfate (MDI)
albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer
Drug: albuterol sulfate (nebulizer)
albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece
Inclusion Criteria:
1. Willing and able to provide written informed consent, either themselves or via legally
acceptable representative, prior to undergoing study procedures
2. Willing and able to comply with study-related procedures/assessments
3. Adults over 18 years of age
4. COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or
saliva specimen taken within the previous 5 days
Exclusion Criteria:
1. 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.
2. Presence of significant comorbidity that, in the opinion of the investigator, makes
the subject unsuitable for participation in the study
3. Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm,
or significant cough response to albuterol
4. 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)
5. Active or incompletely treated pulmonary infections, such as tuberculosis (or known
history of nontuberculosis mycobacterium) over past 12 months
6. Pregnant or currently breast feeding, or a positive urine pregnancy dip test performed
at baseline (women only)
Theravance Biopharma Investigational Site
Kansas City, Kansas, United States
Medical Monitor, Study Director
Theravance Biopharma