A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

Conditions

• Allergic Asthma

Eligibility Criteria

Sex

ALL

Age

17 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
• Placebo — DRUG
  Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
• Asthma therapies — DRUG
  Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Study Details

This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.

Key Dates

Start date

May 31, 2010

Status verified

Oct 2014

Primary completion

Aug 31, 2013

Completion

Aug 31, 2013

Study Design

Enrollment

176 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab
  Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
• Placebo Comparator: Placebo
  Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.

Primary Outcome Measure

Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]

Locations (100)

Find similar trials in Huntsville, AL

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