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

NCT ID: NCT04681079

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-01-18

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]

Conditions

COVID-19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

albuterol sulfate (MDI)

Intervention Type: DRUG

albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer

albuterol sulfate (nebulizer)

Intervention Type: DRUG

albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece

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.

albuterol sulfate (MDI)

Intervention Type: DRUG

albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer

albuterol sulfate (nebulizer)

Intervention Type: DRUG

albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece

Interventions

albuterol sulfate (MDI)

albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer

Intervention Type: DRUG

albuterol sulfate (nebulizer)

albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Theravance Biopharma Investigational Site

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

0192

Identifier Type: -

Identifier Source: org_study_id