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New treatment option for Chronic Obstructive Pulmonary Disease (COPD)
Official title Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
ClinicalTrials.gov ID: NCT07059091
What this study is testing
What is Omalizumab (Xolair®)?
Omalizumab (Xolair®) is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Able and willing to provide informed consent.
- Age \>40 years at screening.
- 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...
You likely can't join if
- 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...
- Reduced life expectancy due to other disease that in the opinion of the investigator may interfere with participation in the study.
See the full eligibility criteria
- Able and willing to provide informed consent.
- Age \>40 years at screening.
- 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...
- Participants of childbearing potential must have negative pregnancy test upon study entry.
- 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 defined with positive skin prick test (SPT) (SPT wheal size at least 3 mm greater than negative control)...
- 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).
- 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.
- 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...
- 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 \ 330 lbs; and total IgE \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Colchester, Vermont, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; San Francisco, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.