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

March 18, 2014 updated by: Genentech, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1899

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of all serious adverse events.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Yamo Deniz, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q2143g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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