Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00396409
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Depigoid — DRUG
    Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)
  • Omalizumab — DRUG
    anti-IgE (Omalizumab) given during the 2006 core study
  • Placebo — DRUG
    Placebo given during the 2006 core study

Study Details

Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Key Dates

Start date
Feb 28, 2006
Status verified
Feb 2017
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

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

Arms

  • Experimental: Depigold+Omalizumab
    Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)
  • Experimental: Depigoid+Placebo
    Depigoid® (grass/rye pollen 50/50) + Placebo

Primary Outcome Measure

Daily Symptom Load [ Time Frame: Recorded daily during the 2007 and 2008 pollen season ]

Related Studies