AsthmaPhase 2NCT00048022
Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
A Phase 2 study testing Dual Integrin Antagonist in people with Asthma, run by Hoffmann-La Roche at 60 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Dual Integrin Antagonist
- How many people
- Not given
- Where
- 60 sitesin 2 countries
- Study dates
- 25 Oct 2002to 2 Feb 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent asthma for more than 1 year
- Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
- In good health as demonstrated by medical history and physical exam
- Negative urine pregnancy test
- Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy
Who cannot join
- Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
- Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
- History of chronic pulmonary diseases other than asthma
- Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
- Current tobacco usage
- Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
Show all 10Show fewer
- History or evidence of drug or alcohol abuse
- Diagnosis or evidence of an infectious illness within one month of Visit 1
- Clinically significant diseases as assessed by the study doctor
- Participation in another clinical study with an experimental drug within one month of start of the study
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States59 sites
Study site
Abingdon, Virginia, 24210
Study site
Asheville, North Carolina, 28801
Study site
Atlanta, Georgia, 30309
Study site
Austin, Texas, 78750
Study site
Bellingham, Washington, 98225
Study site
Boulder, Colorado, 80304
Study site
Canton, Ohio, 44718
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45231
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75231
Study site
Denver, Colorado, 80206
Study site
Eugene, Oregon, 97401
Study site
Farmingdale, New York, 11735
Study site
Forked River, New Jersey, 08731
Study site
Huntington Beach, California, 92647
Study site
Indianapolis, Indiana, 46208
Study site
Iowa City, Iowa, 52240
Study site
Kirkland, Washington, 98034
Study site
Las Vegas, Nevada, 89104
Study site
Lenexa, Kansas, 66219
Study site
Los Angeles, California, 90025
Study site
Los Angeles, California, 90095-1690
Study site
Louisville, Colorado, 80027
Study site
Madison, Wisconsin, 53792-9988
Study site
Medford, Oregon, 97504
Study site
Metairie, Louisiana, 70006
Study site
Mission Viejo, California, 92691
Study site
Missoula, Montana, 59804
Study site
Morgantown, West Virginia, 26505
Study site
Murray, Utah, 84107
Study site
Normal, Illinois, 61761
Study site
North Dartmouth, Massachusetts, 02745
Study site
Oklahoma City, Oklahoma, 73120
Study site
Omaha, Nebraska, 68114
Study site
Philadelphia, Pennsylvania, 19115
Study site
Philadelphia, Pennsylvania, 19140
Study site
Portland, Oregon, 97213
Study site
Providence, Rhode Island, 02906
Study site
Rochester, New York, 14618
Study site
Rockville Centre, New York, 11570
Study site
San Diego, California, 92103
Study site
San Diego, California, 92120
Study site
San Jose, California, 95128
Study site
Sarasota, Florida, 34233
Study site
Seattle, Washington, 98105
Study site
South Burlington, Vermont, 05403
Study site
Sugar Land, Texas, 77478
Study site
Tacoma, Washington, 98405
Study site
Tallahassee, Florida, 32308
Study site
Tamarac, Florida, 33321
Study site
Tampa, Florida, 33609
Study site
Tampa, Florida, 33613
Study site
Teaneck, New Jersey, 07666
Study site
Upland, Pennsylvania, 19013
Study site
Walnut Creek, California, 94598
Study site
Ypsilanti, Michigan, 48197
About this study
The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.
- Conditions
- Asthma
- Being tested
- Dual Integrin Antagonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Integrin AntagonistDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2002 (estimated)
- Study start25 Oct 2002
- Primary completion2 Feb 2004
- Study completion2 Feb 2004
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 Hoffmann-La RocheThe 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
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048022
- Sponsor's protocol ID
- BA16630
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2002
- Last updated
- 19 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT00048022
- Acronym / sponsor ID
- BA16630
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2002 (actual)
- Primary completion
- 2 Feb 2004 (actual)
- Study completion
- 2 Feb 2004 (actual)
- First posted
- 25 Oct 2002 (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 primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persistent asthma for more than 1 year
- Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
- In good health as demonstrated by medical history and physical exam
- Negative urine pregnancy test
- Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy
Key exclusion criteria (10 listed)
- Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
- Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
- History of chronic pulmonary diseases other than asthma
- Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
- Current tobacco usage
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 |
|---|---|---|
| Dual Integrin Antagonist | Drug | – |
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 19 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dual Integrin Antagonist in people with Asthma, run by Hoffmann-La Roche at 60 sites in 2 countries.
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 5 inclusion and 10 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Puerto Rico. 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 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 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 19 Jun 2017.