A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00401596
First received: November 17, 2006
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. Upon successful completion of the screening period (~2 weeks), each subject entered the 24 week study.


Condition Intervention Phase
Asthma
Drug: Xolair (omalizumab)
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled, Open-Label Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Subjects Already Treated With Other Therapies (ALTO)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of all serious adverse events.

Secondary Outcome Measures:
  • Incidence of all adverse events during the treatment phase of the study
  • Incidence of protocol defined asthma exacerbation episodes (AEEs) during the treatment phase of the study
  • Nocturnal symptoms as measured by the modified Inner City Asthma Study Morbidity Assessment.

Estimated Enrollment: 1899
Study Start Date: July 2000
Study Completion Date: July 2002
  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented physician diagnosis of moderate to severe, persistent asthma, defined in the National Heart, Lung, and Blood Institute (NHLBI) guidelines as FEV1 < 80% predicted for height, age, and sex or a history of FEV1 < 80%
  • Between 6 and 75 years old at the time of screening (Visit 1 [Week -2])
  • Current treatment with the following medications: Moderate doses of any inhaled steroid preparation on a daily basis for at least 30 days prior to screening; and/or oral steroids at a stable dose on a daily basis for at least 30 days prior to screening; and currently treated with at least one of the following drugs on a daily basis at a stable dose for at least 30 days prior to screening: long-acting β-adrenergic (salmeterol), leukotriene receptor antagonist (LTRA), xanthine derivatives, or sodium cromoglycate
  • Signed informed consent (in the case of a minor, consent must have been given by the child's parent or legal guardian)
  • Serum IgE level of ≥ 30 IU/mL and ≤ 1300 IU/mL and a body weight ≥ 20 kg and ≤ 150 kg and fell within the protocol-defined dosing table ranges
  • For females of childbearing potential, in the opinion of the investigator, use of an effective method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study
  • Willingness to participate fully for the duration of the study

Exclusion Criteria:

  • Current active AEE defined as requiring initiation or increase in oral steroid dose or treatment with at least a doubling of inhaled steroid dose
  • Thrombocytopenia as evidenced by platelets < 100,000/uL
  • Pregnancy or lactation
  • Previous randomization in this study
  • Use of any experimental drug within 30 days prior to study screening
  • Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • Diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
  • Active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease)
  • History of smoking within 2 years of the study screening visit or history of smoking ≥ 10 pack years
  • Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrinologic or gastrointestinal disease) within the previous 3 months
  • History of neoplasia
  • History of noncompliance to medical regimens
  • Any systemic condition requiring regular administration of immunoglobulin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401596

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Yamo Deniz, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00401596     History of Changes
Other Study ID Numbers: Q2143g
Study First Received: November 17, 2006
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
ALTO

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014