Clinical trial NCT00264849: Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Official title: A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
omalizumab
Severe persistent allergic asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
name: Tanox
First posted: 2005-12-13
Enrollment: 406
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.


Eligibility criteria: Inclusion Criteria:

Patients who met the following criteria were included:

* Males or females of any race, who were 12-75 years of age
* A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
* A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
* A positive prick skin test (diameter of wheal \>= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
* Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
* An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
* Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists for at least 3 months prior to screening and \> 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at randomization
* Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
* Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation

Exclusion Criteria:

Patients who met the following criteria were excluded:

* Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
* A smoking history \>10 pack years
* An active lung disease other than allergic asthma
* Elevated serum IgE levels for reasons other than allergy
* Patients with significant underlying medical conditions

Primary outcomes:
measure: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
timeFrame: Weeks 16 and 32
Secondary outcomes:
measure: Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
timeFrame: Weeks 16 and 32
measure: Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE
timeFrame: Weeks 16 and 32
measure: Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
timeFrame: Weeks 16 and 32
measure: Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE
timeFrame: Weeks 16 and 32
measure: Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
timeFrame: Weeks 16 and 32
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
timeFrame: Baseline, Week 16, Week 32
measure: Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
timeFrame: 32 Weeks
measure: Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period
timeFrame: 32 Weeks
measure: Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32
timeFrame: Weeks 16 and 32
measure: Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
timeFrame: Weeks 16 and 32
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
timeFrame: Baseline, Week 15, Week 31
measure: Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31
timeFrame: Baseline, Week 15, Week 31
measure: Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems
timeFrame: Baseline and Week 31
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Montreal
country: Canada
city: Hvidovre
country: Denmark
city: Berlin
country: Germany
city: Athens
country: Greece
city: Budapest
country: Hungary
city: Dublin
country: Ireland
city: Haifa
country: Israel
city: Roma
country: Italy
city: Oslo
country: Norway
city: Lodz
country: Poland
city: Lisboa
country: Portugal
city: Madrid
country: Spain
city: Stockholm
country: Sweden
city: Bern
country: Switzerland
city: Bursa
country: Turkey
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Siergiejko Z, Swiebocka E, Smith N, Peckitt C, Leo J, Peachey G, Maykut R. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin. 2011 Nov;27(11):2223-8. doi: 10.1185/03007995.2011.620950. Epub 2011 Sep 21.