Actively Recruiting
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Led by Johns Hopkins University · Updated on 2026-02-17
334
Participants Needed
23
Research Sites
272 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent.
- Age greater than 40 years at screening.
- Exposure to combustible tobacco cigarettes over 10 pack-years.
- 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 greater than 15 OR history of at least one moderate or severe COPD exacerbation in the past year.
- Negative pregnancy test for participants of childbearing potential.
- Agreement to use FDA approved contraception methods for female and male participants with reproductive potential during the study.
- Post-bronchodilator FEV1/FVC ratio less than 0.7 and FEV1% predicted less than 80%.
- Sensitization to one or more common indoor allergens (cat, dog, mouse, cockroach, dust mite) confirmed by positive skin prick test or specific IgE testing within 12 months.
- Exposure in the home to the same allergen to which the participant is sensitized based on settled dust measurements.
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with study protocol.
- Living in a location other than a home (e.g., care facility).
- Actively breastfeeding.
- Current diagnosis of asthma.
- Other lung diseases (e.g., cystic fibrosis, pneumoconiosis, bronchiectasis) that are the primary respiratory diagnosis.
- Reduced life expectancy from other diseases that may interfere with study participation.
- Severe medical conditions prohibiting study participation.
- Received or listed for lung transplant.
- Lung volume reduction surgery in the 12 months before screening.
- History of or active infection with Mycobacterium tuberculosis.
- Active parasitic infection diagnosed or treated within 6 months of randomization.
- Currently receiving allergen immunotherapy.
- History of anaphylaxis from medications, foods, or other causes.
- Current prescription for epinephrine autoinjector for severe chronic urticaria.
- Known sensitivity to study drugs or other biologic medications.
- Use of other investigational agents for COPD within the last 90 days (6 months washout for biologics).
- Use of biologic medication for respiratory disease in past 6 months or for non-respiratory disease in past 3 months.
- Use of chronic systemic corticosteroids above 10mg daily prednisone equivalent.
- Systemic corticosteroid treatment for COPD exacerbation within 4 weeks before randomization.
- Weight less than 66 or greater than 330 lbs; total IgE less than 30 IU/mL or greater than 700 IU/mL; or no dosing recommendation based on weight and IgE.
- No inhaled corticosteroid in background for individuals with blood eosinophil count over 300 and history of systemic steroid requiring exacerbation, except if contraindicated (e.g., thrush, osteoporosis, pneumonia in past year).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 23 locations
1
University of Alabama
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
University of Arizona- Tuscon
Tucson, Arizona, United States, 85724
Not Yet Recruiting
3
University of San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
4
National Jewish Health
Denver, Colorado, United States, 80206
Not Yet Recruiting
5
University of Florida
Jacksonville, Florida, United States, 32209
Not Yet Recruiting
6
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Not Yet Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
9
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
10
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
11
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
13
Henry Ford Health
Detroit, Michigan, United States, 48202
Not Yet Recruiting
14
Mount Sinai, Icahn School of Medicine
New York, New York, United States, 10029
Not Yet Recruiting
15
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
16
Cornell University
New York, New York, United States, 10032
Not Yet Recruiting
17
Duke University Medical Center
Durham, North Carolina, United States, 27705
Not Yet Recruiting
18
Temple University
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
19
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
20
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
21
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
22
University of Vermont
Colchester, Vermont, United States, 05446
Not Yet Recruiting
23
Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle
Seattle, Washington, United States, 98108
Not Yet Recruiting
Research Team
K
Kayla Long
CONTACT
H
Heather Hazucha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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