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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: Completed Phase 1 study, sponsored by University of California, Los Angeles.

NCT00203684 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 57 participants
Phase Phase 1

What the finished NCT00203684 record still lists

NCT00203684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Flunisolide-HFA is the first listed.

NCT00203684 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00203684's enrollment target sits among peer trials

57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00203684, the US trial registry maintained by the National Library of Medicine. NCT00203684 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.