Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681079
• Other study ID #: 0192
• Status: Completed
• Start date: May 4, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: January 2022
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 18, 2022
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• albuterol sulfate (MDI)
albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer
• albuterol sulfate (nebulizer)
albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece

Locations

Country	Name	City	State
United States	Theravance Biopharma Investigational Site	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 1