RecruitingPhase 2

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether omalizumab can help people with COPD, a lung disease that makes breathing hard, and allergies. It is for adults age 40 or older who react to certain indoor allergens and are exposed to them at home. The study lasts about 16 months, including 12 months of study drug treatment at a clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must agree to join after learning about the study.
  • You must be age 40 or older and have smoked more than 10 pack-years, such as one pack a day for more than 10 years.
  • You must report that a doctor diagnosed you with COPD and currently use two or three types of long-acting inhaled medicines.
  • You must have a COPD symptom score of at least 15, or at least one flare-up in the past year treated with steroid pills, an emergency room visit, or a hospital stay.
  • After medicine to open your airways, breathing tests must show an FEV1/FVC ratio below 0.7 and FEV1 below 80% of the expected value.
  • An allergy blood test must show a reaction to cat, dog, mouse, cockroach, or dust mites. A test from the past 12 months may count.
  • Dust testing must show enough of the same allergy trigger in your home to meet the study's limits.
  • If you could become pregnant, you must have a negative pregnancy test. Participants who could have children must agree to use FDA-approved birth control during the study.

Who can't join

  • You cannot give written consent or follow study rules, live somewhere other than a home, such as a care facility, or are breastfeeding.
  • You have asthma, another main lung disease that would affect participation, or a serious illness or shortened life expectancy that the study doctor believes would prevent participation.
  • You have had or are listed for a lung transplant, or had a procedure to reduce lung size in the past 12 months.
  • You have or have had tuberculosis, or had an active parasite infection diagnosed or treated within 6 months before treatment assignment.
  • You receive allergy treatment to build tolerance, have had anaphylaxis (a severe allergic reaction), have an active epinephrine auto-injector prescription for severe long-term hives, or are sensitive to the study drug or another biologic medicine.
  • You used another experimental COPD drug in the past 90 days, an experimental biologic within 6 months, a biologic for lung disease within 6 months, or a biologic for another disease within 3 months. Biologics are medicines made using living cells.
  • You take more than 10 mg of prednisone daily, or an equal dose of another whole-body steroid, or took whole-body steroids for a COPD flare-up within 4 weeks before treatment assignment. Certain people with high eosinophils (a type of white blood cell) and a steroid-treated flare-up in the past year must use an inhaled steroid unless there is a medical reason not to.
  • Your weight is below 66 or above 330 pounds, your total IgE (an allergy-related blood protein) is below 30 or above 700 IU/mL, or no dose fits your weight and IgE level. You also cannot join if your GLP-1 medicine dose has been stable for less than 6 months before treatment assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 year. * 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. 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 Exclusion Criteria: * 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 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.

Study sites (23)

AL

AZ

CA

CO

FL

IA

IL

KS

MD

MI

NC

NY

PA

TN

TX

VT

WA