AsthmaPhase 3NCT00401596
A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
A Phase 3 study testing Xolair (omalizumab) in people with Asthma, run by Genentech, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Xolair (omalizumab)
- How many people
- 1,899 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jul 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
About this study
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)
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.
- Conditions
- Asthma
- Being tested
- Xolair (omalizumab)
- Keywords
- ALTO
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xolair (omalizumab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all serious adverse events.
Secondary outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJul 2000
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 1,899 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yamo Deniz, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401596
- Sponsor's protocol ID
- Q2143g
- Status last verified
- Mar 2014
- First submitted
- 17 Nov 2006
- Last updated
- 19 Mar 2014
- Results posted
- No
Publications
Busse WW, Humbert M, Haselkorn T, Ortiz B, Trzaskoma BL, Stephenson P, Garcia Conde L, Kianifard F, Holgate ST. Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol. 2020 Feb;124(2):190-196. doi: 10.1016/j.anai.2019.11.016. Epub 2019 Nov 22.
PubMed 31760132
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00401596
- Acronym / sponsor ID
- Q2143g
- Conditions
- Asthma
- Keywords
- ALTO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,899 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2000
- Study completion
- Jul 2002 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xolair (omalizumab) | Drug | – |
Primary outcome
Incidence of all serious adverse events.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Derived from this study: PubMed 31760132Busse WW, Humbert M, Haselkorn T, Ortiz B, Trzaskoma BL, Stephenson P, Garcia Conde L, Kianifard F, Holgate ST. Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol. 2020 Feb;124(2):190-196. doi: 10.1016/j.anai.2019.11.016. Epub 2019 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yamo Deniz, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xolair (omalizumab) in people with Asthma, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all serious adverse events.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.