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

Conditions

• Allergies
• Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omalizumab (Xolair®) — DRUG
  The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.
• Sodium Chloride (NaCl) 0.9 % — DRUG
  The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.

Study Details

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.

Key Dates

Start date

Feb 12, 2026

Status verified

Feb 2026

Primary completion

Jan 31, 2031

Completion

May 31, 2031

Study Design

Enrollment

334 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Omalizumab injection
  Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment
• Placebo Comparator: Placebo injection
  Placebo for omalizumab used in the study will be commercially packaged 0.9% Sodium Chloride Injection, USP (e.g., normal saline). The injection volumes of normal saline administered will be calculated based upon the volume of active omalizumab expected to be administered based upon weight and total IgE level.

Primary Outcome Measure

Rate of COPD exacerbations [ Time Frame: 12 months ]

Central Contacts

• Kayla Long
  410-502-9048
  [email protected]
• Heather Hazucha
  410-502-0585
  [email protected]

Locations (23)

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