What is omalizumab studying for COPD and allergies?

Omalizumab is being studied to see if it can help people with COPD who are also allergic to common indoor allergens. This trial evaluates if omalizumab can reduce COPD flare-ups in this group over a year. The research is sponsored by Johns Hopkins University to improve understanding of treatment options for COPD with allergies.

Who may be eligible for this COPD clinical trial?

Adults aged 40 years and older with COPD and allergies to certain indoor allergens may be eligible. Participants must have a history of smoking, be on specific inhaled therapies, and meet lung function criteria. Both males and females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase 2

Age: 40Years +

All Genders

ID07059091

Study of Omalizumab Injection for Adults 40 and Older with COPD and Allergies

Led by Johns Hopkins University · Updated on 2026-02-17

334

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether the drug omalizumab can help people aged 40 and older who have Chronic Obstructive Pulmonary Disease COPD and are allergic to common indoor allergens such as pet dander, cockroaches, or dust mites found in their homes. This phase 2 clinical trial aims to understand how omalizumab affects COPD symptoms and exacerbations in this specific group. Participants will receive either omalizumab injections or placebo injections normal saline given under the skin in the arm or leg at a clinic. The dose and frequency of injections are determined by the participants weight and blood IgE levels, with injections given monthly 12 doses or twice monthly 24 doses over a 12-month treatment period. Before treatment, there is a screening period lasting 1 to 3 months, and after the final injection, there will be a follow-up call one month later. During the study, participants will visit the clinic regularly to receive injections and be monitored for side effects. The main outcome measured is the rate of COPD flare-ups during the 12 months of treatment. Participants will also undergo assessments including lung function tests and allergy evaluations. The total time involved in the study is about 16 months from screening through follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years +

All Genders

Eligibility Criteria

You may qualify if you...

Able and willing to provide informed consent.
Age over 40 years at screening.
History of smoking cigarettes for more than 10 pack-years.
Physician diagnosis of COPD and currently using dual or triple long-acting inhaled therapy.
COPD Assessment Test score greater than 15 or at least one moderate or severe COPD exacerbation in the past year.
Negative pregnancy test for participants of childbearing potential upon study entry.
Agreement to use FDA approved contraception for participants with reproductive potential.
Post-bronchodilator FEV1/FVC ratio less than 0.7 and FEV1 percent predicted less than 80%.
Sensitization to one or more common indoor allergens confirmed by skin prick test or specific IgE testing.
Exposure to the allergen to which the participant is sensitized, measured in home settled dust.

You will not qualify if you...

Unable or unwilling to give written informed consent or comply with study protocol.
Living in a care facility or location other than home.
Currently breastfeeding.
Diagnosis of asthma.
Other primary lung diseases like cystic fibrosis, pneumoconiosis, or bronchiectasis.
Reduced life expectancy from other diseases that interfere with study participation.
Severe medical conditions preventing participation.
Received or listed for lung transplant.
Lung volume reduction surgery within 12 months prior to screening.
History or active infection with Mycobacterium tuberculosis.
Active parasitic infection within 6 months.
Currently receiving allergen immunotherapy.
History of anaphylaxis to medications or foods.
Active prescription for epinephrine autoinjector for severe chronic urticaria.
Known sensitivity to study drug or other biologic medications.
Use of investigational COPD agents within last 90 days or biologics within specified washout periods.
Use of chronic systemic corticosteroids above 10 mg prednisone daily.
Recent systemic corticosteroid treatment within 4 weeks.
Weight below 66 or above 330 pounds; total IgE outside dosing range or no dosing recommendation.
No inhaled corticosteroids in background regimen for certain high eosinophil count participants unless contraindicated due to specific conditions.

Research Team

Kayla Long

Heather Hazucha

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Study of Omalizumab Injection for Adults 40 and Older with COPD and Allergies

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria