AsthmaPhase 2ReHICSNCT00695604
Repeated High-dose Inhaled Corticosteroids for Asthma
A Phase 2 study testing Fluticasone in people with Asthma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2011
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Physician diagnosis of asthma.
- Age ≥18 years and ≤50 years
- Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
- Treatment for asthma with:
- daily inhaled corticosteroids and long-acting beta2-agonists, AND
- as-needed use of a short-acting beta2-agonist
Who cannot join
- History of >10 pack-year tobacco use
- Other pulmonary or cardiac diagnosis that is actively being treated
- History of adverse events or allergy to fluticasone
- Systemic corticosteroid therapy within 7 days of study visit
- Inability to obtain written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.
- Conditions
- Asthma
- Being tested
- Placebo, Fluticasone
- Keywords
- Acute asthma, fluticasone, inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo via MDI.
FluticasoneDrug
Fluticasone MDI.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Comparator
All patients assigned to this group will receive:
1. Placebo via Metered Dose Inhaler (MDI).
2. Albuterol via MDI. Receives: Drug: Placebo |
| 2 | Active comparator | Active Comparator
All patients assigned to this group will receive:
1. Fluticasone via MDI.
2. Albuterol via MDI. Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airflow inflammation.
Measured: Pre-study and post-study drug administration
Secondary outcomes (1)
Airflow obstruction.
Measured: Pre-study and post-study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Study was not able to be completed, no results analyzed.
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 ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Krishnan, MD, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695604
- Sponsor's protocol ID
- 15322B
- Acronym
- ReHICS
- Status last verified
- May 2018
- First submitted
- 10 Jun 2008
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated High-dose Inhaled Corticosteroids for Asthma
- ClinicalTrials.gov ID
- NCT00695604
- Acronym / sponsor ID
- ReHICS / 15322B
- Conditions
- Asthma
- Keywords
- Acute asthma, fluticasone, inhaled corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not able to be completed, no results analyzed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2008 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Jun 2008 (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.
The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo Comparator All patients assigned to this group will receive: 1. Placebo via Metered Dose Inhaler (MDI). 2. Albuterol via MDI. |
| 2 | Active comparator | Drug: FluticasoneActive Comparator All patients assigned to this group will receive: 1. Fluticasone via MDI. 2. Albuterol via MDI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physician diagnosis of asthma.
- Age ≥18 years and ≤50 years
- Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
- Treatment for asthma with:
Key exclusion criteria (5 listed)
- History of >10 pack-year tobacco use
- Other pulmonary or cardiac diagnosis that is actively being treated
- History of adverse events or allergy to fluticasone
- Systemic corticosteroid therapy within 7 days of study visit
- Inability to obtain written informed consent
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 |
|---|---|---|
| PlaceboPlacebo via MDI. | Drug | 1 |
| FluticasoneFluticasone MDI. | Drug | 2 |
Primary outcome
Airflow inflammation.
Time frame: Pre-study and post-study drug administration
1 secondary outcome
Airflow obstruction.
Time frame: Pre-study and post-study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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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.
Jerry Krishnan, MD, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone in people with Asthma, run by University of Chicago 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 May 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Airflow inflammation. (time frame: Pre-study and post-study drug administration). It is what the study was designed to measure, not a finding.
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 8 May 2018; AzTrials last refreshed its copy on 31 Oct 2026.