AsthmaPhase 2NCT00587288
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
A Phase 2 study testing Reslizumab and Saline in people with Asthma, run by Ception Therapeutics at 30 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Reslizumab and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Apr 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- male or female subjects aged ≥ 18 to 75 years at time of screening
- female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
- confirmation of asthma
- symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
- requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
- requirement for >/= 3% eosinophils in induced sputum at Screening
Who cannot join
- a clinically important event that would interfere with study schedule or procedure or compromise subject safety
- a diagnosis of hypereosinophilic syndrome
- an underlying lung disorder
- a current smoker
- use of systemic immunosuppressive agents within 6 months of study
- current use of systemic corticosteroids
Show all 16Show fewer
- received attenuated live attenuated vaccines within three months prior to study entry
- expected to be poorly compliant with study drug, procedures, visits
- aggravating factors that are inadequately controlled
- participation in any investigational drug or device study within 30 days prior to study entry
- participation in biologics study within 3 months prior to study entry
- receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
- female subjects who are pregnant or nursing
- concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
- concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
- current suspected drug and/or alcohol abuse
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States24 sites
Allergy and Asthma Specialists
Blue Bell, Pennsylvania, 19422
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Allergy & Clinical Research Center
Centennial, Colorado, 80112
David Bernstein
Cincinnati, Ohio, 45229
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, 80907
Pulmonary Disease & Critical Care Associates, P.A.
Columbia, Maryland, 21044
Health Sciences Research at Asthma & Allergy
Cortland, New York, 13045
National Jewish Medical & Research Center
Denver, Colorado, 80206
Allergy, Asthma and Sinus Center
Greenfield, Wisconsin, 53228
University of Wisconsin-Madison, Allergy/Asthma Clinical Research Unit
Madison, Wisconsin, 53972
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504
Clinical Research Institute
Minneapolis, Minnesota, 55402
Vanderbilt Asthma Sinus Allergy Program & Research Centers
Nashville, Tennessee, 37203
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Children'S Hospital of Orange County-Pediatric Subspecialty Faculty
Orange, California, 92868
The Asthma & Allergy Center
Papillion, Nebraska, 68046
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Virginia Adult & Pediatric Allergy and Asthma
Richmond, Virginia, 23229
Virginia Commonwealth University
Richmond, Virginia, 23298
Asthma, Inc
Seatle, Washington, 98105
Washington University of School of Medicine
St Louis, Missouri, 63110
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Wake Forest Univeristy Health Services
Winston-Salem, North Carolina, 27157
Canada6 sites
Heritage Medical Research Clinic, University of Calgary
Calgary, Alberta, T2N4N1
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Queen's University, Richardson's House
Kingston, Ontario, K7L 2V6
Hopital du Sacre-Couer de Montreal
Montreal, Quebec, H4J1C5
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Hopital Laval
Québec, Quebec, G1V4G5
About this study
Official title: An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
Read the detailed description
Objectives:
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
Secondary:
- To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
- To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
- To assess the safety and tolerability of reslizumab in subjects with asthma.
- Conditions
- Asthma
- Being tested
- Reslizumab, Saline
- Keywords
- Cinquil™, Reslizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabBiological
Also called Cinquil™, CEP-38072, CTx55700
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Reslizumab 3 mg/kg | Experimental | Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles Receives: Biological: Reslizumab |
| Placebo | Placebo comparator | Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.
Measured: Baseline through End of Therapy (up to 15 weeks)
Secondary outcomes (6)
Percentage of ACQ Responders at End of Therapy
Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.
Measured: Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.
Measured: Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Percent Predicted FEV1
The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant's percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).
Measured: Baseline, End of Therapy (up to 15 weeks)
Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels
Measured: End of Screening or Baseline, End of Therapy (up to 15 weeks)
Percentage of Participants With Clinical Asthma Exacerbations (CAEs)
A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.
Measured: up to 15 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation
Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as "severe." If drug relationship of an AE was missing, the AE was reported as "probably related." WFT=withdrawn from treatment.
Measured: From start of study drug through 15 weeks + 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ception Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, MD, Study director, Cephalon (Ception)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587288
- Sponsor's protocol ID
- Res-5-0010
- Status last verified
- Jul 2016
- First submitted
- 4 Jan 2008
- Last updated
- 17 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, Wilkins HJ, Henkel T, Nair P; Res-5-0010 Study Group. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1125-32. doi: 10.1164/rccm.201103-0396OC. Epub 2011 Aug 18.
PubMed 21852542
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
- ClinicalTrials.gov ID
- NCT00587288
- Acronym / sponsor ID
- Res-5-0010
- Conditions
- Asthma
- Keywords
- Cinquil™, Reslizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ception TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Cephalon
- Study start
- Apr 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 26 Apr 2016
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 determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
Detailed description
Objectives:
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
Secondary:
- To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
- To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
- To assess the safety and tolerability of reslizumab in subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reslizumab 3 mg/kg | Experimental | Biological: ReslizumabReslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
| Placebo | Placebo comparator | Other: SalineSaline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- written informed consent
- male or female subjects aged ≥ 18 to 75 years at time of screening
- female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
- confirmation of asthma
- symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
Key exclusion criteria (16 listed)
- a clinically important event that would interfere with study schedule or procedure or compromise subject safety
- a diagnosis of hypereosinophilic syndrome
- an underlying lung disorder
- a current smoker
- use of systemic immunosuppressive agents within 6 months of study
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 |
|---|---|---|
| ReslizumabAlso: Cinquil™, CEP-38072, CTx55700 | Biological | Reslizumab 3 mg/kg |
| Saline | Other | Placebo |
Primary outcome
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline through End of Therapy (up to 15 weeks)
The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.
6 secondary outcomes
Percentage of ACQ Responders at End of Therapy
Time frame: Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)
Time frame: Baseline, End of Therapy (up to 15 weeks)
Change From Baseline to End of Therapy in Percent Predicted FEV1
Time frame: Baseline, End of Therapy (up to 15 weeks)
Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels
Time frame: End of Screening or Baseline, End of Therapy (up to 15 weeks)
Percentage of Participants With Clinical Asthma Exacerbations (CAEs)
Time frame: up to 15 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation
Time frame: From start of study drug through 15 weeks + 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21852542Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, Wilkins HJ, Henkel T, Nair P; Res-5-0010 Study Group. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1125-32. doi: 10.1164/rccm.201103-0396OC. Epub 2011 Aug 18.
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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.
Sponsor's Medical Expert, MD study director
Cephalon (Ception)
30 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 Reslizumab and Saline in people with Asthma, run by Ception Therapeutics at 30 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 7 inclusion and 16 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 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score (time frame: Baseline through End of Therapy (up to 15 weeks)). 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 NCT00587288, 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 17 Aug 2016.