Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

Sponsor
Shanghai Zhangjiang Biotechnology Limited Company
Study ID
NCT01976208
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150\~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg\~750mg，then dosing interval is every 2 weeks.
  • placebo — DRUG

Study Details

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Key Dates

Start date
Dec 31, 2010
Status verified
Dec 2015
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

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

Arms

  • Experimental: Omalizumab
    During the 4\~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the following treatment phase, patients continued to receive optimized BUD and Omalizumab for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks. The dosage of Omalizumab received was based on body weight and serum IgE.
  • Placebo Comparator: placebo
    During the 4\~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the treatment phase, patients continued to receive placebo and optimized BUD for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks.

Primary Outcome Measure

The proportion of patients with asthma exacerbation [ Time Frame: 32 weeks ]

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