AsthmaPhase 2NCT00141791
Study Evaluating Etanercept in Moderate to Severe Asthma
A Phase 2 study testing Etanercept in people with Asthma, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in United States.
Trial summary
The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Etanercept
- How many people
- 120 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2005to Jul 2006
- 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
- Moderate to severe persistent asthma for at least 1 year
- Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
- Subjects must be on a high-dose inhaled corticosteroid (ICS)
Who cannot join
- Previous treatment with etanercept
- Current use of cigarettes
- Significant concurrent medical conditions at the time of screening
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Birmingham, Alabama, 35209
Study site
Boston, Massachusetts, 02115
Study site
Covington, Louisiana, 70433
Study site
Denver, Colorado, 80206
Study site
Madison, Wisconsin, 53792
Study site
Portland, Oregon, 97213
Study site
Richmond, Virginia, 23229
Study site
Rockville Centre, New York, 11570
Study site
Sarasota, Florida, 34233
Study site
Tallahassee, Florida, 32308
Study site
Valrico, Florida, 33594
Study site
Wheaton, Maryland, 20902
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.
- Conditions
- Asthma
- Being tested
- Etanercept
- Keywords
- Asthma, Anti-Asthmatic Agents, Receptors, Tumor Necrosis Factor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Secondary outcomes (1)
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141791
- Sponsor's protocol ID
- 0881A8-205
- Status last verified
- Aug 2009
- First submitted
- 30 Aug 2005
- Last updated
- 7 Aug 2009
- Results posted
- No
Publications
Holgate ST, Noonan M, Chanez P, Busse W, Dupont L, Pavord I, Hakulinen A, Paolozzi L, Wajdula J, Zang C, Nelson H, Raible D. Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. Eur Respir J. 2011 Jun;37(6):1352-9. doi: 10.1183/09031936.00063510. Epub 2010 Nov 25.
PubMed 21109557
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT00141791
- Acronym / sponsor ID
- 0881A8-205
- Conditions
- Asthma
- Keywords
- Asthma, Anti-Asthmatic Agents, Receptors, Tumor Necrosis Factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 1 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.
The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe persistent asthma for at least 1 year
- Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
- Subjects must be on a high-dose inhaled corticosteroid (ICS)
Key exclusion criteria (3 listed)
- Previous treatment with etanercept
- Current use of cigarettes
- Significant concurrent medical conditions at the time of screening
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 |
|---|---|---|
| Etanercept | Drug | – |
Primary outcome
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
1 secondary outcome
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
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 7 Aug 2009.
- Derived from this study: PubMed 21109557Holgate ST, Noonan M, Chanez P, Busse W, Dupont L, Pavord I, Hakulinen A, Paolozzi L, Wajdula J, Zang C, Nelson H, Raible D. Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. Eur Respir J. 2011 Jun;37(6):1352-9. doi: 10.1183/09031936.00063510. Epub 2010 Nov 25.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etanercept in people with Asthma, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites 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 3 inclusion and 3 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 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 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.
What does the primary outcome measure?
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141791, which also lists 1 linked publication.
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 7 Aug 2009.