Clinical Trial: Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase IV, Randomized, Double-Blind, Placebo-Controlled Exploratory Study of Xolair (Omalizumab) for Treatment of Idiopathic Angioedema in Patients Who Remain Symptomatic

Brief Summary: The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to 2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be life- threatening especially when affecting tissues within the respiratory tract. No clear guidelines exist for management of this important condition for clinicians. Current therapies typically include avoidance of potential triggers and use of medications either for prophylaxis or for acute events, such as antihistamines, corticosteroids, and epinephrine. There remains a critical need for therapeutic options to provide more effective prophylaxis.

Detailed Summary: This study is a randomized, double-blind, placebo-controlled, parallel group trial which will study the effects of omalizumab on patients with 2 or more episodes of Idiopathic Angioedema (IAE) in the past 6 months, despite current therapy. This study has three periods; screening, treatment, and follow-up. Subjects in the screening period will be consented and screened for eligibility criteria. 40 qualified individuals will enter the treatment period. Individuals will be randomized to either monthly subcutaneous administration of omalizumab 300mg (20 subjects) versus monthly placebo injection (20 subjects) in addition to their previously prescribed management plan for a total of 6 months. Individuals will then enter a follow-up period of 4 months. Study visits will occur monthly during the treatment period for update of clinical status and administration of omalizumab/placebo injection. After, the treatment period individuals will be seen twice for follow-up period. The entire study will consist of 10 study visits and will last approx. 10 months.
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Number of angioedema episodes [ Time Frame: 9 months ]

To estimate the effect of omalizumab in reducing the severity of angioedema episodes in patients with idiopathic angioedema


Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life [ Time Frame: 9 months ]

To estimate the effect of omalizumab in improving quality of life in idiopathic angioedema subjects using the Quality of Life Questionnaire for Patients with Recurrent Swelling Episodes (AE-QOL).


Original Secondary Outcome: Quality of Life [ Time Frame: 9 months ]

To estimate the effect of omalizumab in improving quality of life in idiopathic angioedema subjects.


Information By: University of Wisconsin, Madison

Dates:
Date Received: November 15, 2016
Date Started: March 2017
Date Completion: August 2018
Last Updated: February 28, 2017
Last Verified: February 2017