A Phase 1 interventional study of Flunisolide-HFA and Flunisolide-CFC in Asthma and Distal Lung Inflammation, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Diagnostic
Asthmatics have inflammation in the large airways (tubes through which air travels in and out of the lungs). The large airways are located in the central lung. New research shows that asthmatics also have inflammation in the small airways. The small airways are located in the peripheral lung (the parts of the lung away from the central lung).
Until now, most of the inhaled medications available have been made up of big particles that never reach the peripheral lung. The purpose of this study is to try to measure the level of inflammation in the peripheral lung in asthmatics and see if this inflammation can be decreased with different types of inhaled corticosteroids. The investigators will check airway inflammation before and after use of an inhaled corticosteroid that has a large particle size and should only reach the large airways (Flunisolide-CFC), and before and after use of an inhaled, small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA).
Subjects will make 6 study visits over two phases of the study. In the first phase, the investigators will collect baseline information about subjects while they are using placebo (inactive substance). In the second phase, subjects will take either the large or small particle corticosteroid.
Visits will involve questionnaires and various tests measuring lung function (such as spirometry, forced oscillation, and methacholine challenge). Exhaled nitric oxide will be measured as an indication of inflammation. Subjects will also measure and make note of lung function at home twice daily using a peak expiratory flow meter. Two of the visits will involve fiberoptic bronchoscopy so that the investigators may collect cells and tissue samples without surgery. Another two of the visits will involve the use of high resolution computed tomography (HRCT) scans to indirectly evaluate disease in distant parts of the lungs.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 57 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The use of the following medications will exclude subjects from entering the study:
Eligibility will be determined by an investigator using the above inclusion/exclusion criteria.
No subjects will be excluded based on race or gender. Subjects must be between 18 and 50 in order to avoid greater risks of bronchoscopy and, in those under 18, exposure to radiation. To avoid risks, women will not be enrolled if pregnant, lactating or of childbearing potential and unwilling to undertake appropriate precautions.
In the first phase, the investigators will collect baseline information about subjects while they are using placebo (inactive substance). In the second phase, subjects will take the small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA).
Drug: Flunisolide-HFA
In the first phase, the investigators will collect baseline information about subjects while they are using placebo (inactive substance). In the second phase, subjects will take the large particle corticosteroid that should only reach the large airways (Flunisolide-CFC).
Drug: Flunisolide-CFC
an inhaled, small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA)
Also known as: Small particle corticosteroid
an inhaled corticosteroid that has a large particle size and should only reach the large airways (Flunisolide-CFC)
Also known as: Large particle corticosteroid
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles