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Mentored Patient-Oriented Research Career Development Award

StatusCompleted
PhasePhase 1
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Phase: Phase 1/2 to Phase 1

    Trial status: Recruiting to Completed; Enrollment target: 57; Interventions: Flunisolide-HFA (Drug) to Flunisolide-CFC (Drug), Flunisolide-HFA (Drug); and 2 more

    Show all 6 changes in this update
    • Notable Phase: Phase 1/2 to Phase 1
    • Minor Trial status: Recruiting to Completed
    • Minor Enrollment target: 57
    • Minor Interventions: Flunisolide-HFA (Drug) to Flunisolide-CFC (Drug), Flunisolide-HFA (Drug)
    • Minor Site details revised
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Contacts/Locationsv5

  2. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v4

  3. Minor

    Eligibility criteria expanded, about 3 words

    Study title revised

    Show what changed: Eligibility criteria
    Inclusion Criteria: AgeAged 18 to 50 years. Younger subjects are excluded due to greate [...] risks of bronchoscopy. Mild to moderate persistent asthma (forced expiratory volume in 1 second [FEV1] greater than or equal to 70% predicted {Hankinson, 1999 #266}; PC20 less than or equal to 8 mg/ml) and currently using only short acting inhaled beta agonists as needed for control of asthma symptoms. Exclusion Criteria: § The use of the following medications will exclude subjects f [...] ic, psychiatric, or respiratory (other than asthma) disease b) Eligibility will be determined by an investigator using the abo [...] [...]
    Show what changed: Study title
    Mentored Patient-Oriented Research Career Development Award.

    Study Identification, Study Status, Study Description, Eligibilityv3

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  5. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Asthma, Distal Lung Inflammation
Enrollment 57 participants
Updated on ClinicalTrials.gov