Chronic Obstructive Pulmonary Disease (COPD)Phase 2COPD-OMANCT07059091
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
A Phase 2 study testing Omalizumab (Xolair®) and Sodium Chloride (NaCl) 0.9 % in people with Chronic Obstructive Pulmonary Disease (COPD) and Allergies, run by Johns Hopkins University at 23 sites in United States.
Trial summary
This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Allergies
- What is being tested?
- Omalizumab (Xolair®) and Sodium Chloride (NaCl) 0.9 %
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 23 sitesUnited States
- Study dates
- 12 Feb 2026to May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent.
- Age ≥ 40 years at screening.
- Primary combustible tobacco cigarette exposure >10 pack-years.
- Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS/LABA/LAMA, ICS/LABA, LABA/LAMA).
- COPD Assessment Test (CAT) score of ≥ 15 OR history of at least one documented moderate (requiring treatment with oral corticosteroids) or severe (requiring ED visit or hospitalization) COPD exacerbation in the past year.
- Participants of childbearing potential must have negative pregnancy test upon study entry.
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- Female (and male) participants with reproductive potential must agree to use FDA approved methods of contraception for duration of study.
- Post-bronchodilator FEV1/FVC ratio < 0.7 and FEV1% predicted < 80%.
- Sensitization to one or more of five common indoor allergens including cat, dog, mouse, cockroach, dust mite confirmed with specific IgE. Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted
- Exposure to the same allergen to which individual is sensitized based on measurement in home settled dust (1 U/g cockroach, 1 μg/g mouse, 2 μg/g dust mite, (Der f 1), 8 μg/g for cat and dog).
- Participants on a stable dose for >6 months will be allowed to enroll
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Live in a location other than home (i.e., care facility)
- Actively breastfeeding.
- Current asthma diagnosis.
- Other lung disease (cystic fibrosis, pneumoconiosis, bronchiectasis or otherwise) that is considered the primary respiratory diagnosis and would interfere with participation in the study
- Reduced life expectancy due to other disease that in the opinion of the investigator may interfere with participation in the study.
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- Participants with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Received or listed for a lung transplant.
- Surgical or bronchoscopic lung volume reduction surgery in the 12 months prior to screening.
- History of infection or active infection due to Mycobacterium tuberculosis
- Active parasitic infection diagnosed and/or treated within 6 months of randomization
- Currently receiving allergen immunotherapy.
- History of anaphylaxis from medications, foods or otherwise.
- Current active prescription for epinephrine autoinjector for treatment of severe chronic urticaria.
- Known sensitivity to study drug(s) or another biologic medication.
- Use of any other investigational agent for COPD in the last 90 days. If the other investigational agent being used is a biologic agent, this must be washed out for 6 months prior to randomization.
- Active use of biologic medication (monoclonal antibody) for treatment of respiratory disease in the past 6 months (benralizumab, omalizumab, mepolizumab, resilizumab, dupliumab, tezepelumab, or other similar medication or use of biologic medication for treatment of any non-respiratory disease in the past 3 months.
- Use of chronic systemic corticosteroids at doses above 10mg daily prednisone or the equivalent.
- Use of systemic corticosteroid course for acute exacerbation of COPD within 4 weeks of randomization.
- Weight < 66 lbs (30kg) or >330 lbs (150 kg); and total IgE < 30 IU/mL or >700 IU/mL; or no available dosing recommendation based on weight and total IgE level.
- No ICS in background regimen for individuals with blood eosinophil count of >300 and systemic steroid requiring exacerbation in the past year, except in case of contraindication to ICS such as thrush, osteoporosis, or pneumonia in the past year.
- Participants who have been on a stable GLP-1 agonist dose for less than 6 months prior to randomization.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 21 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Wendy Warshal, 734-232-2841, warshal@med.umich.edu
MeiLan Han
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21231
Kayla Long, 410-502-9048, klong33@jhu.edu
Niru Putcha
- Not yet recruiting
University of Alabama
Birmingham, Alabama, 35294
Necole Harris, 205-934-9240, nharris@uabmc.edu
Michael Wells
- Active, not recruiting
University of Illinois at Chicago
Chicago, Illinois, 60608
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Jenny Hixon, 312-926-0975, j-franzen@northwestern.edu
Ravi Kalhan
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Jessica Parumoottil, 312-563-2168, Jessica_Parumoottil@rush.edu
James Moy
- Recruiting
University of Vermont
Colchester, Vermont, 05446
Olivia Garrow, 802-847-2160, olivia.johnson@uvmhealth.org
Anne Dixon
- Not yet recruiting
National Jewish Health
Denver, Colorado, 80206
Juno Pak, 303-398-1443, pakj@njhealth.org
Barry Make
- Not yet recruiting
Henry Ford Health
Detroit, Michigan, 48202
Muzhda Hashmi, 313-900-5452, mhashmi2@hfhs.org
Alan Baptist
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27705
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Laura Bertrand, 713-798-2681, laura.bertrand@bcm.tmc.edu
Nicola Hanania
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Eric Garcia, 319-353-8862, eric-garcia@uiowa.edu
Alejandro Comellas
- Not yet recruiting
University of Florida
Jacksonville, Florida, 32209
Alexis Luis, 904-244-0908 ext. Alexis.Luis@ja
Vandana Seeram
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Nicole Hall, 913-588-1987, nhall@kumc.edu
Mario Castro
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Courtney Lehman, 615-421-8172, courtney.a.lehman@vumc.org
Katherine Cahill
- Not yet recruiting
Mount Sinai, Icahn School of Medicine
New York, New York, 10029
Maria Wong, 212-241-2779, mariaantonia.wong@mssm.edu
Linda Rogers
- Recruiting
Columbia University
New York, New York, 10032
Jotti Saroya, 212-305-0251, tks2127@cumc.columbia.edu
Emily DiMango
- Not yet recruiting
Cornell University
New York, New York, 10032
Jose Romero, 212-305-4675, jlr4002@med.cornell.edu
Robery Kaner
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Francine McGonagle, 215-707-2682, Francine.McGonagle@tuhs.temple.edu
Nathaniel Marchetti
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Tiffany Ditter, 412-648-6276, dittertl2@upmc.edu
Frank Sciurba
- Not yet recruiting
University of San Francisco
San Francisco, California, 94143
Shannen Rico, 415-203-8234, shannen.recio@ucsf.edu
Stephanie Christenson
- Not yet recruiting
Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle
Seattle, Washington, 98108
Brianna Moss, 206-277-4166, Brianna.Moss@va.gov
Laura Freemster
- Recruiting
University of Arizona- Tuscon
Tucson, Arizona, 85724
Alyssandra Rivera, 520-626-6387, arivera59@arizona.edu
Fernando Martinez
About this study
Official title: Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.
Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.
Read the detailed description
This study is for people 40 years and older with COPD who also have allergens in their home that they are allergic to, like pet dander, cockroaches or dust mites.
- Being tested
- Omalizumab (Xolair®), Sodium Chloride (NaCl) 0.9 %
- Keywords
- lung disease, COPD, allergies
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypersensitivity, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab (Xolair®)Drug
The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.
Sodium Chloride (NaCl) 0.9 %Drug
The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab injection | Active comparator | Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment Receives: Drug: Omalizumab (Xolair®) |
| Placebo injection | Placebo comparator | Placebo for omalizumab used in the study will be commercially packaged 0.9% Sodium Chloride Injection, USP (e.g., normal saline). The injection volumes of normal saline administered will be calculated based upon the volume of active omalizumab expected to be administered based upon weight and total IgE level. Receives: Drug: Sodium Chloride (NaCl) 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COPD exacerbations
To determine the efficacy of omalizumab injection in reducing the annualized rate of moderate or severe exacerbations (primary outcome) over the course of 12 months among individuals with COPD having sensitization and exposure to any of a panel of common indoor aeroallergens.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start12 Feb 2026
- Primary completionJan 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter phase II placebo-controlled, masked, randomized superiority clinical trial of omalizumab vs placebo in individuals with COPD having sensitization and exposure to indoor allergens.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Genentech, Inc., American Lung Association Asthma Clinical Research Centers, American Lung Association
- Responsible party
- Sponsor
- Investigators
- Nirupama Putcha, Principal investigator, Johns Hopkins School of MedicineElizabeth Sugar, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059091
- Sponsor's protocol ID
- IRB00498976
- Other IDs
- 1U01AI177195
- Acronym
- COPD-OMA
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
- ClinicalTrials.gov ID
- NCT07059091
- Acronym / sponsor ID
- COPD-OMA / IRB00498976
- Keywords
- lung disease, COPD, allergies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Genentech, Inc., American Lung Association Asthma Clinical Research Centers, American Lung Association
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 10 Jul 2025 (actual)
- 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.
This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.
Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.
Detailed description
This study is for people 40 years and older with COPD who also have allergens in their home that they are allergic to, like pet dander, cockroaches or dust mites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicenter phase II placebo-controlled, masked, randomized superiority clinical trial of omalizumab vs placebo in individuals with COPD having sensitization and exposure to indoor allergens.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab injection | Active comparator | Drug: Omalizumab (Xolair®)Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment |
| Placebo injection | Placebo comparator | Drug: Sodium Chloride (NaCl) 0.9 %Placebo for omalizumab used in the study will be commercially packaged 0.9% Sodium Chloride Injection, USP (e.g., normal saline). The injection volumes of normal saline administered will be calculated based upon the volume of active omalizumab expected to be administered based upon weight and total IgE level. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able and willing to provide informed consent.
- Age ≥ 40 years at screening.
- Primary combustible tobacco cigarette exposure >10 pack-years.
- Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS/LABA/LAMA, ICS/LABA, LABA/LAMA).
- COPD Assessment Test (CAT) score of ≥ 15 OR history of at least one documented moderate (requiring treatment with oral corticosteroids) or severe (requiring ED visit or hospitalization) COPD exacerbation in the past year.
Key exclusion criteria (22 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Live in a location other than home (i.e., care facility)
- Actively breastfeeding.
- Current asthma diagnosis.
- Other lung disease (cystic fibrosis, pneumoconiosis, bronchiectasis or otherwise) that is considered the primary respiratory diagnosis and would interfere with participation in the 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 |
|---|---|---|
| Omalizumab (Xolair®)The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic. | Drug | Omalizumab injection |
| Sodium Chloride (NaCl) 0.9 %The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic. | Drug | Placebo injection |
Primary outcome
Rate of COPD exacerbations
Time frame: 12 months
To determine the efficacy of omalizumab injection in reducing the annualized rate of moderate or severe exacerbations (primary outcome) over the course of 12 months among individuals with COPD having sensitization and exposure to any of a panel of common indoor aeroallergens.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Nirupama Putcha principal investigator
Johns Hopkins School of Medicine
Elizabeth Sugar, PhD principal investigator
Johns Hopkins University
23 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 Omalizumab (Xolair®) and Sodium Chloride (NaCl) 0.9 % in people with Chronic Obstructive Pulmonary Disease (COPD) and Allergies, run by Johns Hopkins University at 23 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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Long (410-502-9048, klong33@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of COPD exacerbations (time frame: 12 months). 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 4 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.