Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01066104
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Rhinosinusitis
  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xolair placebo — DRUG
    two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
  • Xolair (omalizumab) — DRUG
    two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Study Details

The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your nose). The investigators also want to find out if it is safe to use (whether it causes side effects).

Key Dates

Start date
Dec 31, 2009
Status verified
May 2017
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Xolair placebo
    Xolair placebo 150-375 mg is administered subcutaneously (SC) every 2 or 4 weeks depending on the patient's baseline serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg) ). Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.
  • Active Comparator: Xolair (omalizumab)
    Xolair (omalizumab) 150-375 mg is administered subcutaneously (SC) every 2 or 4 weeks depending on the patient's baseline serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.

Primary Outcome Measure

Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan. [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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