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Asthma mucus study pulled before it began
NCT ID NCT04514913
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to use a special camera (virtual navigation bronchoscopy) to collect samples from mucus plugs in the lungs of people with asthma. The goal was to compare inflammation markers between plugged and non-plugged airways, and with healthy volunteers. However, the study was withdrawn before enrolling anyone, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Expected to start
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Feb 2023
An estimate. Start dates often move.
- Finished
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Feb 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants with asthma who present with or without mucus plugs, as well as healthy controls, all between the ages of 18 and 70.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Group 1: Healthy Controls Inclusion Criteria: * Male or female between the ages of 18 and 70 years at Visit 1 and at least 50% whose age is \> 40 years (to ensure age balance among groups and anticipating that group 3 subjects will be older). * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * Able to perform reproducible spirometry according to ATS criteria. Exclusion Criteria: * Upper respiratory tract infection (URI) within the previous 6 weeks. * History of lung disease. * Smoking of tobacco or other recreational inhalants in last month and/or \>10 pack-year smoking history. * Currently pregnant. * History of allergic rhinitis. * Laboratory evidence of atopy (blood eosinophils \> 0.4 cells/dL, IgE \> 165 IU/mL) * History of unstable cardiovascular disease. * BMI \> 45 * Currently taking anticoagulants. Group 2: Asthmatic Subjects without Mucus Plugs Inclusion Criteria: * Male or female between the ages of 18 and 70 years at Visit 1 and at least 50% whose age is \> 40 years (to ensure age balance among groups and anticipating that group 3 subjects will be older). * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * Able to perform reproducible spirometry according to ATS criteria. * Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine PC20 ≤ 16 mg/mL). Historical methacholine data from previous studies conducted in the past 5 years at the UCSF ACRC will be allowed. * Clinical history of asthma per patient report or medical record. * Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater. Exclusion Criteria: * Asthma exacerbation or URI within the previous 6 weeks. * Currently pregnant. * Smoking of tobacco or other recreational inhalants in last month and/or \>10 pack-year smoking history. * Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease. * History of unstable cardiovascular disease. * BMI \> 45. * Currently taking anticoagulants. Group 3: Asthmatic Subjects with Mucus Plugs Inclusion: * Male or female between the ages of 18 and 70 years at Visit 1. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * Able to perform reproducible spirometry according to ATS criteria. * Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine PC20 ≤ 16 mg/mL). Historical methacholine data from previous studies conducted in the past 5 years at the UCSF ACRC will be allowed. * Clinical history of asthma per patient report or medical record. * Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater. * A MDCT lung scan indicating a mucus plug accessible by bronchoscopy in at least one airway. Exclusion Criteria: * Asthma exacerbation or URI within the previous 6 weeks. * Currently pregnant. * Smoking of tobacco or other recreational inhalants in last month and/or \>10 pack-year smoking history. * Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease. * History of unstable cardiovascular disease. * BMI \> 45. * Currently taking anticoagulants. * Mucus plugs inaccessible by bronchoscope.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UCSF Airway Clinical Research Center
San Francisco, California, 94143, United States
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