Mentored Patient-Oriented Research Career Development Award

StatusCompleted
PhasePhase 1

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Record History

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  1. Notable Phase: Phase 1/2 to Phase 1v5 Show 5 more changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: 57
    • Interventions: Flunisolide-HFA (Drug) to Flunisolide-CFC (Drug), Flunisolide-HFA (Drug)
    • Site details revised
    • Study arms: 0 to 2
  2. Re-verified, no change to tracked fieldsv4
  3. Minor Study title revised
    • Eligibility criteria expanded, about 3 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00203684
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Asthma, Distal Lung Inflammation
Related terms Asthma
Enrollment 57 participants
Updated on ClinicalTrials.gov