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

Completed

• Conditions: COVID-19
• Interventions: Drug: albuterol sulfate (MDI); Drug: albuterol sulfate (nebulizer)

• Registration Number: NCT04681079
• Lead Sponsor: Theravance Biopharma

Brief 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.

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 Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Study Start: 2021-05-04
• Primary Completion: 2021-11-22
• Status Verified: 2022-01
• Study Completion: 2022-01-18
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crossover Sequence 2	albuterol sulfate (MDI)	Subjects randomized to receive commercially available albuterol sulfate via nebulizer with filtered mouthpiece first, followed by albuterol sulfate via MDI with spacer.
Crossover Sequence 2	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.
Crossover Sequence 1	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 1	albuterol sulfate (MDI)	Subjects randomized to receive commercially available albuterol sulfate via MDI with spacer first, followed by albuterol sulfate via nebulizer with filtered mouthpiece.

Primary Outcome Measures

Name	Time	Method
Viral Load	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.

Trial Locations

Locations (1)

Theravance Biopharma Investigational Site; 🇺🇸 Kansas City, Kansas, United States