Moderate-to-severe Allergic AsthmaPhase 4EDURONCT04195958
A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
A Phase 4 study testing Omalizumab in people with Moderate-to-severe Allergic Asthma, run by Genentech, Inc. at 12 sites in United States.
Trial summary
This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate-to-severe Allergic Asthma
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Nov 2020to 18 Oct 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed asthma for at least 12 months prior to screening
- Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen
- Able to comply with asthma control medication adherence, digital monitoring data collection, and eDiary requirements during screening period
- Able to safely complete incremental exercise tolerance at screening
- Pre-bronchodilator FEV1 of 40%-80% of predicted at screening
- Documented history of variable airflow obstruction or hyper-responsiveness within 12 months of study entry
Show all 10Show fewer
- On inhaled corticosteroids (ICS) therapy at a total daily dose greater than or equal to (≥)500 micrograms (ug) of fluticasone propionate or equivalent and at least one second controller (LABA, LAMA, LTRA) for ≥3 months prior to screening
- Uncontrolled asthma during the screening period, defined as an ACQ-5 ≥0.75 score
- Sleep disturbance due to asthma (e.g. cough, wheezing etc.) in the opinion of the investigator
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use adequate contraception during the treatment period and for 60 days after the final dose of study drug.
Who cannot join
- Known history of anaphylaxis/hypersensitivity to omalizumab
- Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening
- Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening
- Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period
- Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period
- Isolated diagnosis of exercise induced asthma without chronic symptoms
Show all 16Show fewer
- History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma
- Current malignancy or history of malignancy within 5 years prior to screening
- Unable to complete cardiopulmonary exercise testing and/or perform physical activity due to underlying cardiac, neurologic or orthopedic conditions
- Ongoing physician-treated sleep disorder that is unrelated to asthma within 6 months prior to screening
- Current smoker or past smoker with >10 pack years
- Known HIV infection at screening
- Known acute or chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
- Infection that resulted in hospital admission, required treatment with intravenous or intramuscular antibiotics within 4 weeks prior to screening, or any active infection that required treatment with oral antibiotics within 2 weeks prior to screening
- Active tuberculosis requiring treatment within 12 months prior to screening
- History of alcohol, drug, or chemical abuse within 6 months of screening
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109-0934
American Health Research Inc.
Charlotte, North Carolina, 28277
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44016
National Jewish Health
Denver, Colorado, 80206
University of Iowa Hospitals & Clinics; Internal Medicine
Iowa City, Iowa, 52242
Lenox Hill Hospital
New York, New York, 10075
Broward Research Center
Pembroke Pines, Florida, 33024
Temple Uni Medical Center; Pulmonary & Critical Care Medicine
Philadelphia, Pennsylvania, 19140
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Swedish Health Services
Seattle, Washington, 98122
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: A Multicenter, Open-Label, Single-Arm Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma
This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.
- Conditions
- Moderate-to-severe Allergic Asthma
- Being tested
- Omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Omalizumab will be administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Not described Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 24
Secondary outcomes (6)
Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 24
Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 24
Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 24
Percentage of Participants With Adverse Events
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 28
Percentage of Participants With Serious Adverse Events
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 28
Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Measured: From Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start30 Nov 2020
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Why it stopped: Due to low enrollment, this study was terminated early.
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 Moderate-to-severe Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195958
- Sponsor's protocol ID
- ML41615
- Acronym
- EDURO
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2019
- Last updated
- 15 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single-Arm Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma
- ClinicalTrials.gov ID
- NCT04195958
- Acronym / sponsor ID
- EDURO / ML41615
- Conditions
- Moderate-to-severe Allergic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment, this study was terminated early.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: Omalizumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician-diagnosed asthma for at least 12 months prior to screening
- Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen
- Able to comply with asthma control medication adherence, digital monitoring data collection, and eDiary requirements during screening period
- Able to safely complete incremental exercise tolerance at screening
- Pre-bronchodilator FEV1 of 40%-80% of predicted at screening
Key exclusion criteria (16 listed)
- Known history of anaphylaxis/hypersensitivity to omalizumab
- Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening
- Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening
- Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period
- Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period
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 |
|---|---|---|
| OmalizumabOmalizumab will be administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening. | Drug | Omalizumab |
Primary outcome
Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)
Time frame: From Baseline to Week 24
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
6 secondary outcomes
Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor
Time frame: From Baseline to Week 24
Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR
Time frame: From Baseline to Week 24
Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor
Time frame: From Baseline to Week 24
Percentage of Participants With Adverse Events
Time frame: From Baseline to Week 28
Percentage of Participants With Serious Adverse Events
Time frame: From Baseline to Week 28
Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
Time frame: From Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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.
Clinical Trials study director
Genentech, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Moderate-to-severe Allergic Asthma, run by Genentech, Inc. at 12 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 10 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: stopped early, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 15 Mar 2022). 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?
Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR) (time frame: From Baseline to Week 24). 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 15 Mar 2022.