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OpenTrials
Completed

NCT Number: NCT04681079

Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Theravance Biopharma Investigational Site

Kansas City, Kansas, 66160, United States

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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