Health TrialsbyHealthPanel

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

ConditionsChronic Obstructive Pulmonary Disease (COPD)Allergies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: Omalizumab injectionActive comparator 1 intervention
Group B: Placebo injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of COPD exacerbations

To determine the efficacy of omalizumab injection in reducing the annualized rate of moderate or severe exacerbations (primary outcome) over the course of 12 months among individuals with COPD having sensitization and exposure to any of a panel of common indoor aeroallergens.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Genentech, Inc.

Collaborator

American Lung Association Asthma Clinical Research Centers

Collaborator

American Lung Association

Collaborator

Source ClinicalTrials.gov
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