Chronic Obstructive Pulmonary Disease study: Omalizumab vs Sodium Chloride
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®)?
This is an investigational injectable medicine being studied to see if it can help people with COPD and allergies. It is designed to block a specific protein in the body called IgE, which is involved in allergic reactions.
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 study is testing whether omalizumab can improve symptoms in people with COPD and allergies.
- Who it's for
- You may be able to join if you have COPD and are allergic to something.
- What's involved
- You will receive injections of omalizumab at a clinic every few weeks. You will also have a phone call after your last visit.
- Time commitment
- The study lasts about 16 months, with 1‑3 months of screening, 12 months of clinic visits, and a follow‑up call one month later.
- 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.
- 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...
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.
- 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...
- 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 confirmed with specific IgE.
- 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
- 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 (150 kg); 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...
- Participants who have been on a stable GLP-1 agonist dose for less than 6 months prior to randomization.
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Colchester, Vermont, 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, but 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?
This study is enrolling now at Tucson, Arizona, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.