AsthmaPhase 1NCT00203684
Mentored Patient-Oriented Research Career Development Award
A Phase 1 study testing Flunisolide-HFA and Flunisolide-CFC in people with Asthma and Distal Lung Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Distal Lung Inflammation
- What is being tested?
- Flunisolide-HFA and Flunisolide-CFC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 50 years. Younger subjects are excluded due to greater concerns with respect to risks from radiation and bronchoscopy in children; older subjects due to greater 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.
Who cannot join
- The use of the following medications will exclude subjects from entering the study:
- Oral or parenteral steroids within 6 months
- Inhaled corticosteroids within 3 months
- Antileukotrienes, b-adrenergic blocking agents, inhaled cromolyn sodium or nedocromil, macrolide antibiotics, or investigational drugs within 1 month
- Drugs or exposures which, in the opinion of the investigators, could influence study results
- Tobacco within 1 year or less than or equal to 5 pack years.
Show all 12Show fewer
- Pregnant women, lactating women, or women of childbearing age not willing to take precautions to avoid becoming pregnant during the study.
- Subjects with upper respiratory infection or receiving an influenza vaccine within 6 weeks of the study.
- Subjects with a history of allergy or adverse reaction to inhaled beta agonists or methacholine.
- Subjects with clinically significant evidence of cardiovascular, central nervous system, endocrine, gastrointestinal, hematopoietic, hepatic, psychiatric, or respiratory (other than asthma) disease
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Asthma and Cough Center
Los Angeles, California, 90095
About this study
Official title: The Effects of Different Sized Inhaled Corticosteroids on Peripheral Lung Inflammation in Asthma Assessed Through Lung Tissue Samples (SMART Protocol)
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).
Read more
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.
- Conditions
- Asthma, Distal Lung Inflammation
- Being tested
- Flunisolide-HFA, Flunisolide-CFC
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flunisolide-HFADrug
Also called Small particle corticosteroid
an inhaled, small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA)
Flunisolide-CFCDrug
Also called Large particle corticosteroid
an inhaled corticosteroid that has a large particle size and should only reach the large airways (Flunisolide-CFC)
| Study group | Role | What they receive |
|---|---|---|
| Small particle corticosteroid | Other | 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). Receives: Drug: Flunisolide-HFA |
| Large particle corticosteroid | Other | 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). Receives: Drug: Flunisolide-CFC |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Zeidler, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203684
- Sponsor's protocol ID
- 5K23RR018538-03
- Other IDs
- NIH grant #5K23RR018538-03
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Sized Inhaled Corticosteroids on Peripheral Lung Inflammation in Asthma Assessed Through Lung Tissue Samples (SMART Protocol)
- ClinicalTrials.gov ID
- NCT00203684
- Acronym / sponsor ID
- 5K23RR018538-03
- Conditions
- Asthma, Distal Lung Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small particle corticosteroid | Other | Drug: Flunisolide-HFAIn 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). |
| Large particle corticosteroid | Other | Drug: Flunisolide-CFCIn 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 to 50 years. Younger subjects are excluded due to greater concerns with respect to risks from radiation and bronchoscopy in children; older subjects due to greater 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.
Key exclusion criteria (12 listed)
- The use of the following medications will exclude subjects from entering the study:
- Tobacco within 1 year or less than or equal to 5 pack years.
- Pregnant women, lactating women, or women of childbearing age not willing to take precautions to avoid becoming pregnant during the study.
- Subjects with upper respiratory infection or receiving an influenza vaccine within 6 weeks of the study.
- Subjects with a history of allergy or adverse reaction to inhaled beta agonists or methacholine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flunisolide-HFAAlso: Small particle corticosteroidan inhaled, small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA) | Drug | Small particle corticosteroid |
| Flunisolide-CFCAlso: Large particle corticosteroidan inhaled corticosteroid that has a large particle size and should only reach the large airways (Flunisolide-CFC) | Drug | Large particle corticosteroid |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Zeidler, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flunisolide-HFA and Flunisolide-CFC in people with Asthma and Distal Lung Inflammation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.