Status:
COMPLETED
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
Lead Sponsor:
Novartis
Collaborating Sponsors:
Genentech, Inc.
Tanox
Conditions:
Allergic Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will te...
Eligibility Criteria
Inclusion
- Patients were eligible for inclusion if they met all of the following criteria:
- Informed Consent
- Patients who were informed of the study procedures and medications and provided their written informed consent
- Demographics
- Male or female
- Any race
- Ages 18 - 55 years
- Body weight \>=20 kg and \<=150 kg
- Total serum IgE concentration \>=30 and \<=700 IU/mL at Visit 0
- Disease Definitions/Medications
- History of at least moderate persistent allergic asthma (consistent with Global Initiative for Asthma \[GINA\] guidelines of \>=1 year in duration
- On a stable asthma treatment regimen including inhaled corticosteroids for the preceding 4 weeks
- An FEV1 while withholding short-acting beta-agonists for at least 6 hours and long-acting beta-agonists for at least 12 hours, of \>=75% of the predicted value at Visit 0
- Evidence of reversible airway obstruction, as defined by an increase in FEV1 of \>=12% between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit 0 or within the preceding year
- Documented sensitivity to perennial aeroallergens, as evidenced by a positive skin test (wheal \>=5mm greater than saline control) to at least 1 of 3 perennial aeroallergens (house dust mite, cat, or dog) at Visit 0 or within the preceding year
- Average PEFR variability \<=20% (calculated as \[(PM PEF - AM PEF)/(PM PEF + AM PEF)/2 x 100) during the 2-week screening period
- Pre-specified level of nocturnal asthma symptoms (i.e., a mean nocturnal asthma score of \>0 and \<=0.5) and a mean combined clinical symptom score (nocturnal, morning, and daytime) of \>0 and \<=3 during the screening period
- Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years (i.e., 1 pack \[20 cigarettes\] per day for 10 years)
- Judged to be in good physical and mental health (except for his/her asthma), based on medical history, physical examination, and routine laboratory data, and appeared to be able to successfully complete this trial
Exclusion
- Patients were to be excluded from participation if they met any of the following criteria:
- Pulmonary
- History of intubation for asthma
- Asthma exacerbation requiring treatment with systemic steroids within the preceding 3 months
- Asthma exacerbation requiring treatment in an emergency department or a hospital admission in the preceding 6 months
- Upper respiratory tract infection or sinusitis within the preceding 4 weeks
- History of an anaphylactic allergic reaction (except to stinging insects, foods, or drugs other than omalizumab)
- History of treatment with immunotherapy to any allergen within past 3 years
- History of aspirin or non steroidal anti-inflammatory drug (NSAID)-related asthma; patients could have been included in NSAIDs use was avoided for the duration of the study
- General Medical
- History of or current malignancy
- Any clinically significant uncontrolled systemic disease or a history of such disease (e.g., infectious, hematologic, renal, hepatic, endocrinologic, gastrointestinal, or cardiovascular disease) within the previous 3 months
- Clinically significant laboratory abnormalities at Visit 1
- Platelet levels \<=130 x 10 9/L at visit 1
- Women of childbearing potential who were not practicing a medically approved contraception method (e.g., oral, subcutaneous, mechanical, or surgical contraception), as well as women who were pregnant or nursing
- History of hypersensitivity to any ingredients, including excipients (sucrose, histidine, or polysorbate 20) of the study medication or drugs related to omalizumab (e.g., monoclonal anti-bodies or polyclonal gammaglobulin)
- Severe medical condition(s) that, in the view of the investigator, prohibited participation in the study
- Previous treatment with omalizumab within 1 year of screening
- Considered by the investigator to be potentially unreliable or who may not have reliably attended study visits
- History of drug or alcohol abuse
- Procedural
- Unable to perform acceptable, reproducible spirometry, or PEFR measurements
- Unable or unwilling to comply with the study procedures as determined during the screening phase, including adequate completion of the diary
- Medications
- Patient took the following medications before Visit 0. These medications were not permitted during the trial unless otherwise specified:
- Oral, intravenous, intramuscular, or intra-articular corticosteroids within 4 weeks
- Beta-adrenergic antagonists (including ocular preparations) within 1 week
- Antihistamines within 1 week; after skin testing was completed (Visit 0), antihistamines could be used as needed for the remainder of the study
- Intravenous gammaglobulin or immunosuppressants within 4 weeks
- Tricyclic antidepressants within 1 week
- Investigational drugs within 4 weeks
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00267202
Start Date
December 1 2005
End Date
April 1 2008
Last Update
September 14 2016
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States