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

NCT00396409 | Completed Phase 3 Results

• 1 other identifier: CIGE025ADE03
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Daily Symptom Load

  The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.

  Recorded daily during the 2007 and 2008 pollen season

Secondary Outcomes (11)

• Asthma/Rhinoconjunctivitis Symptom Severity Score

  Recorded daily during the 2007 and 2008 pollen season

• Asthma/Rhinoconjunctivitis Rescue Medication Score

  Recorded daily during the 2007 and 2008 pollen season

• Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator

  52 Weeks (2007) and 104 Weeks (2008) after completion of core study

• Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient

  52 Weeks (2007) and 104 Weeks (2008) after completion of core study

• Asthma Control Questionnaire (ACQ)

  52 Weeks (2007) and 104 Weeks (2008) after completion of core study

Study Arms (2)

Depigold+Omalizumab

EXPERIMENTAL

Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)

Drug: Depigoid; Drug: Omalizumab

Depigoid+Placebo

EXPERIMENTAL

Depigoid® (grass/rye pollen 50/50) + Placebo

Drug: Depigoid; Drug: Placebo

Interventions

Depigoid DRUG

Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)

Depigoid+Placebo; Depigold+Omalizumab

Omalizumab DRUG

anti-IgE (Omalizumab) given during the 2006 core study

Also known as: Xolair

Depigold+Omalizumab

Placebo DRUG

Placebo given during the 2006 core study

Depigoid+Placebo

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Females of childbearing potential: pregnancy, birth control,breast-feeding
• Concurrent diseases/conditions and history of other diseases/conditions
• 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).
• patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
• Ingredient hypersensitivity
• 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).
• patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigator site

Nuremberg, Germany

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Study Start Date: February 2006 (core study)

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals, Basel +41 61 324 1111.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 30, 2017
• Results First Posted: June 3, 2011

Record last verified: 2017-02

Locations

DE (1)