Clinical trial NCT00396409: Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Official title: A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.

This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Eligibility criteria: Inclusion Criteria:

* Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
* Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within \> 2 previous seasons
* patients with a positive RAST (\>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
* Patients with FEV1 \> 80% of the predicted normal value for the patient at screening \[V1\](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).

Exclusion Criteria:

* Females of childbearing potential: pregnancy, birth control,breast-feeding
* Concurrent diseases/conditions and history of other diseases/conditions

  1. patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).
  2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
* Ingredient hypersensitivity

  1. patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
  2. patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.

Primary outcomes:
measure: Daily Symptom Load
timeFrame: Recorded daily during the 2007 and 2008 pollen season
Secondary outcomes:
measure: Asthma/Rhinoconjunctivitis Symptom Severity Score
timeFrame: Recorded daily during the 2007 and 2008 pollen season
measure: Asthma/Rhinoconjunctivitis Rescue Medication Score
timeFrame: Recorded daily during the 2007 and 2008 pollen season
measure: Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
timeFrame: Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Work Productivity and Activity Impairment
timeFrame: 52 Weeks (2007) and 104 Weeks (2008) after completion of core study
measure: Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)
timeFrame: Assist during 2007 and 2008 pollen season
measure: Lung Function as Assessed by Peak Expiratory Flow (PEF)
timeFrame: Assist during 2007 and 2008 pollen season
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Novartis Investigator site
Study officials:
affiliation: Novartis Pharmaceuticals, Basel +41 61 324 1111.
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: