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NCT00203684 · ClinicalTrials.gov registry record · Phase 1
Mentored Patient-Oriented Research Career Development Award
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00203684 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 57 participants.
The verdict
NCT00203684, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Flunisolide-HFA
- DRUG Flunisolide-CFC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00203684
The ClinicalTrials.gov registry entry for NCT00203684 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Flunisolide-HFA is the first listed.
NCT00203684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00203684 about?
NCT00203684 is a clinical study titled "Mentored Patient-Oriented Research Career Development Award". 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 pa...
What is the current status of trial NCT00203684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants.
What interventions are being tested in trial NCT00203684?
The interventions under investigation include: Flunisolide-HFA (DRUG), Flunisolide-CFC (DRUG).
Who is sponsoring clinical trial NCT00203684?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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