Phase 2 Chronic Rhinosinusitis Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be male or female and at least 18 years old.
• If you are a woman who could become pregnant, you must be using an approved form of birth control (such as the pill, injection, implant, condom, IUD, or have had your tubes tied); women who have had a full hysterectomy or have been through menopause for at least two years are also eligible.
• You must have been diagnosed with chronic rhinosinusitis (long-term sinus disease), meaning you have had at least two major symptoms — such as facial pain/pressure, headaches, nasal congestion, nasal drainage, or reduced/lost sense of smell — for at least 3 months in a row.
• You must have an abnormal sinus scan or camera examination showing sinus disease in at least two sinus areas, documented within 3 months of joining.
• You must have nasal polyps (small growths in the nose) or swollen nasal tissue on both sides of your nose, visible in specific sinus areas, with a minimum polyp score of 4 on a nasal examination.
• You must have a confirmed or past history of allergy to a year-round airborne allergen (such as dust mites or pet dander), shown by a skin test or blood test.
• Your blood IgE level (an allergy-related protein) must be between 30 and 1500 IU/mL, and your body weight must be between 30 and 150 kg (about 66–330 lbs), to match the study medication dosing requirements.
• Your symptom score at the start of the study must be at least 5 out of 15.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or of childbearing age and not using an approved form of birth control.
• People who do not meet the medical requirements for the study drug, Xolair (omalizumab) (confirm with trial site).
• People who are currently taking a beta-blocker medication (a type of heart or blood pressure medicine).
• People who have a known allergy or sensitivity to Xolair (omalizumab).
• People who currently have an active bacterial sinus infection with visible pus on examination or an untreated fluid/air pocket seen on a sinus scan.
• People who have taken antibiotics within 3 weeks before the screening visit.
• People with poorly controlled moderate-to-severe asthma who needed a course of steroid tablets within 6 weeks of joining the study (those on a very low daily maintenance dose of Prednisone of 5 mg or less may still be eligible, as long as the dose stays the same during the study).
• People who have had repeated, uncontrolled nosebleeds within the past 6 weeks.
• People with a history of certain conditions, including low antibody levels in the blood, cystic fibrosis, bronchiectasis, immotile cilia syndrome, a systemic granulomatous disease, cancer or a strong family history of cancer, or recent cocaine use.
• People who have smoked cigarettes within the past 3 years.
• People with serious heart problems, uncontrolled diabetes, chronic kidney or liver disease, HIV, or other active uncontrolled infections, or who have had major surgery within 3 months of the screening visit.
• People who have a significant history of not following medical treatment plans, or who are unable to give informed consent.
• People with alcohol or drug abuse or dependence within the past 3 months.
• People with significantly abnormal liver, kidney, or blood test results (confirm with trial site for specific values).
• People who have taken an oral or systemic steroid burst (a short high-dose course of steroids) within 6 weeks of joining the study.
• People who have taken part in another clinical trial or used any other experimental medication within the 30 days before enrolling.

Important: Always verify eligibility with the trial site directly before applying.