AsthmaPhase 4DEARNCT02937168
An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation
A Phase 4 study testing Reslizumab and Fludeoxyglucose F 18 (FDG) in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This is an exploratory study with the following primary objectives: 1) to establish that PET/CT of the lung can reliably distinguish healthy, non-asthmatic participants from participants with severe asthma and an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that reslizumab produces… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Reslizumab and Fludeoxyglucose F 18 (FDG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 24 May 2017
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 through 50 years of age.
- Females that are either surgically sterile, are 2 years postmenopausal, or have a negative pregnancy test at screening.
- Females of childbearing potential (not surgically sterile or 2 years postmenopausal), have to use a medically accepted method of contraception and have to agree to continue to use of this method for the duration of the study and for 5 months after study drug administration.
- Participants with less that 10-pack year history of smoking.
- Have a previous diagnosis of asthma.
- Participants taking inhaled fluticasone at a dosage of at least 440 micrograms (mcg) daily, or equivalent.
Show all 9Show fewer
- The participant's baseline asthma therapy must be stable for 30 days prior to screening and judged by their treating physician to be able to continue without dosage changes throughout the study.
- Participants with a blood eosinophil level of at least 400 cells/microliter (cells/μL) at screening. Participants with a blood eosinophil level below 400 cells/μL will be given 2 additional screening opportunities to determine blood eosinophil levels.
- Additional criteria apply; please contact the investigator for more information.
Who cannot join
- Participants requiring treatment with oral, intramuscular, or IV corticosteroids within 6 weeks of the Part 1 baseline visit for an asthma exacerbation.
- Participants with any other confounding underlying lung disorder including but not limited to: bronchiectasis, chronic obstructive pulmonary disorder, smoking greater than or equal to (≥)10 pack year history, pulmonary fibrosis, emphysema, cystic fibrosis, and lung cancer.
- Participants diagnosed with diabetes mellitus.
- Participants with pulmonary conditions and blood eosinophilia other than eosinophilic asthma.
- Participants with clinically meaningful comorbidity that can interfere with the study schedule or procedures, or compromise the participant's safety.
- Participants that are current smokers (that is, have smoked within the last 12 months prior to screening).
Show all 20Show fewer
- Participants using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to screening. Participants whose treatment with anti-IgE mAb therapy (omalizumab) is considered ineffective by their physician may be included as potential participants when:
- The omalizumab (Xolair) therapy has been discontinued.
- The participant's blood eosinophil level meets inclusion criteria.
- Participants who have previously received an anti-hIL-5 mAb (for example, reslizumab, mepolizumab [Nucala]) or anti-IL-5 receptor mAb (eg, benralizumab). Participants whose treatment with mepolizumab or benralizumab is considered ineffective by their physician may be included as potential participants when:
- The mepolizumab or benralizumab therapy has been discontinued.
- The participant's blood eosinophil level meets inclusion criteria.
- Participants who had concurrent infection or disease that may preclude assessment of active asthma.
- Participants with a history of concurrent immunodeficiency (human immunodeficiency virus or acquired immunodeficiency syndrome or congenital immunodeficiency).
- Participants that had an active parasitic infection within 6 months prior to screening.
- Participants with any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Known hypersensitivity to study drug or to FDG/contrast agents
- Treatment with metformin.
- Compromised renal function.
- Additional criteria apply; please contact the investigator for more information.
Trial locations and contacts
1 site in 1 country.
United States1 site
Teva Investigational Site 13808
New Brunswick, New Jersey, 08901
About this study
Official title: Distribution of Eosinophils in Asthma After Reslizumab (DEAR). A 7-Week, Placebo-Controlled, Double-Blinded, Parallel-Group, Imaging Study Using Positron Emission Tomography/Computer Tomography (PET/CT) to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation in Patients With Eosinophilic Asthma
This is an exploratory study with the following primary objectives: 1) to establish that PET/CT of the lung can reliably distinguish healthy, non-asthmatic participants from participants with severe asthma and an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that reslizumab produces a reduction in lung inflammation in participants with severe asthma and an eosinophilic phenotype .
- Conditions
- Asthma
- Being tested
- Reslizumab, Fludeoxyglucose F 18 (FDG), Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabDrug
Reslizumab will be administered as per the dose and schedule specified in the arm.
Fludeoxyglucose F 18 (FDG)Drug
FDG will be administered by IV infusion prior to each PET/CT scan.
PlaceboDrug
Placebo matching to reslizumab will be administered as per the schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: PET/CT Scan | Experimental | Healthy participants will have 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants will receive Fluorodeoxyglucose F-18 (FDG) as part of the PET/CT procedures and will provide sputum/blood samples. Receives: Drug: Fludeoxyglucose F 18 (FDG) |
| Part 2: Reslizumab | Experimental | Reslizumab 3.0 milligrams/kilogram (mg/kg) will be administered by intravenous (IV) infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6. Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples. Receives: Drug: Reslizumab; Drug: Fludeoxyglucose F 18 (FDG) |
| Part 2: Placebo | Placebo comparator | Matching placebo will be administered by IV infusion at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6. Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples. Receives: Drug: Fludeoxyglucose F 18 (FDG); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)
GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Measured: Baseline (Day 1) of Part 1
Part 1: Average Global Lung Glycolysis (GLG) at Day 8
GLG is the total FDG uptake in the whole lung. ROI was drawn around lung boundary in each axial slice. SUV mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Measured: Day 8
Part 2: Change From Baseline to Week 4 in GLG
Measured: Baseline, Week 4
Part 2: Change From Baseline to Week 4 in Lung Parenchyma (LP) SUV Mean
Measured: Baseline, Week 4
Secondary outcomes (5)
Part 2: Change From Baseline to Week 4 in Blood Eosinophil Counts
Measured: Baseline, Week 4
Change From Baseline to Week 4 in Forced Expiratory Volume in 1 Second (FEV1)
Measured: Baseline, Week 4
Change From Baseline to Week 4 in Fractional Exhaled Nitric Oxide (FeNO)
Measured: Baseline, Week 4
Change From Baseline to Week 4 in Asthma Quality of Life Questionnaire (AQLQ) Score
Measured: Baseline, Week 4
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start8 May 2017
- Primary completion24 May 2017
- Study completion24 May 2017
Why it stopped: The study was terminated early due to challenges in recruitment. The decision to terminate the study was not related to any safety issues or concerns.
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937168
- Sponsor's protocol ID
- C38072-AS-40105
- Acronym
- DEAR
- Status last verified
- Nov 2021
- First submitted
- 14 Oct 2016
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Eosinophils in Asthma After Reslizumab (DEAR). A 7-Week, Placebo-Controlled, Double-Blinded, Parallel-Group, Imaging Study Using Positron Emission Tomography/Computer Tomography (PET/CT) to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation in Patients With Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT02937168
- Acronym / sponsor ID
- DEAR / C38072-AS-40105
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to challenges in recruitment. The decision to terminate the study was not related to any safety issues or concerns.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study with the following primary objectives: 1) to establish that PET/CT of the lung can reliably distinguish healthy, non-asthmatic participants from participants with severe asthma and an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that reslizumab produces a reduction in lung inflammation in participants with severe asthma and an eosinophilic phenotype .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: PET/CT Scan | Experimental | Drug: Fludeoxyglucose F 18 (FDG)Healthy participants will have 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants will receive Fluorodeoxyglucose F-18 (FDG) as part of the PET/CT procedures and will provide sputum/blood samples. |
| Part 2: Reslizumab | Experimental | Drug: Reslizumab, Drug: Fludeoxyglucose F 18 (FDG)Reslizumab 3.0 milligrams/kilogram (mg/kg) will be administered by intravenous (IV) infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6. Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples. |
| Part 2: Placebo | Placebo comparator | Drug: Fludeoxyglucose F 18 (FDG), Drug: PlaceboMatching placebo will be administered by IV infusion at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6. Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female, 18 through 50 years of age.
- Females that are either surgically sterile, are 2 years postmenopausal, or have a negative pregnancy test at screening.
- Females of childbearing potential (not surgically sterile or 2 years postmenopausal), have to use a medically accepted method of contraception and have to agree to continue to use of this method for the duration of the study and for 5 months after study drug administration.
- Participants with less that 10-pack year history of smoking.
- Have a previous diagnosis of asthma.
Key exclusion criteria (20 listed)
- Participants requiring treatment with oral, intramuscular, or IV corticosteroids within 6 weeks of the Part 1 baseline visit for an asthma exacerbation.
- Participants with any other confounding underlying lung disorder including but not limited to: bronchiectasis, chronic obstructive pulmonary disorder, smoking greater than or equal to (≥)10 pack year history, pulmonary fibrosis, emphysema, cystic fibrosis, and lung cancer.
- Participants diagnosed with diabetes mellitus.
- Participants with pulmonary conditions and blood eosinophilia other than eosinophilic asthma.
- Participants with clinically meaningful comorbidity that can interfere with the study schedule or procedures, or compromise the participant's safety.
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 |
|---|---|---|
| ReslizumabReslizumab will be administered as per the dose and schedule specified in the arm. | Drug | Part 2: Reslizumab |
| Fludeoxyglucose F 18 (FDG)FDG will be administered by IV infusion prior to each PET/CT scan. | Drug | Part 1: PET/CT Scan, Part 2: Placebo, Part 2: Reslizumab |
| PlaceboPlacebo matching to reslizumab will be administered as per the schedule specified in the arm. | Drug | Part 2: Placebo |
Primary outcome
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)
Time frame: Baseline (Day 1) of Part 1
GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Part 1: Average Global Lung Glycolysis (GLG) at Day 8
Time frame: Day 8
GLG is the total FDG uptake in the whole lung. ROI was drawn around lung boundary in each axial slice. SUV mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Part 2: Change From Baseline to Week 4 in GLG
Time frame: Baseline, Week 4
Part 2: Change From Baseline to Week 4 in Lung Parenchyma (LP) SUV Mean
Time frame: Baseline, Week 4
5 secondary outcomes
Part 2: Change From Baseline to Week 4 in Blood Eosinophil Counts
Time frame: Baseline, Week 4
Change From Baseline to Week 4 in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 4
Change From Baseline to Week 4 in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline, Week 4
Change From Baseline to Week 4 in Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, Week 4
Number of Participants With Adverse Events (AEs)
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reslizumab and Fludeoxyglucose F 18 (FDG) in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. 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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 9 Nov 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Aug 2019). 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?
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1) (time frame: Baseline (Day 1) of Part 1). The study lists 4 primary outcomes in all. 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 9 Nov 2021.