AsthmaPhase 4NCT00567476
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
A Phase 4 study testing Omalizumab, Inhaled corticosteroids (ICS) and Long-acting beta 2-adrenergic agonist (LABA) in people with Asthma, run by Novartis at 1 site in Brazil.
Trial summary
This study investigated asthma-related quality of life in Brazilian patients using omalizumab. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab, Inhaled corticosteroids (ICS) and Long-acting beta 2-adrenergic agonist (LABA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 to 75 years-old during screening visit.
- Body weight > 20 kg and < 150 kg.
- Daily or persistent asthma symptoms.
- Night symptoms at least once a week.
- Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal value and continuing asthma symptoms.
- FEV1 increased > 12% from baseline within 30 minutes of inhaled (up to 400 mcg) or nebulized (up to 5 mg) salbutamol.
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- Subject taking more than 500 mcg/day of fluticasone or equivalent associated to a long-acting β2-agonist.
- Inhaled corticosteroid and long-acting beta-2 adrenergic agonist (LABA) doses that remained fixed during the last 12 weeks prior to screening.
- Medical history of at least two episodes of asthma exacerbation treated with systemic corticoid or at least one severe asthma exacerbation treated with systemic corticoid and hospitalization or emergency room visit in the last 12 months prior to screening.
- Positive skin prick test (diameter of wheal > 3mm) to at least one perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to which the subject was likely to be exposed during the study.
- Subject capable to read and understand asthma related quality of life questionnaire (Juniper's questionnaire).
Who cannot join
- Pregnant, nursing female subjects.
- Female subjects without current acceptable contraceptive method.
- Previous history of allergy or hypersensitivity to omalizumab.
- Subjects with prior treatment with omalizumab.
- Subjects with medical history of psychiatric disorder.
- Subject had been treated with systemic corticosteroid for any reason other than asthma.
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- Subject took β2 antagonist medication in the last 3 months prior to screening visit.
- Subject took protocol prohibited medication prior to screening.
- Medical history of food or drug related severe anaphylactoid reactions.
- Medical history of antibiotics allergy. Patients were included if the antibiotics to which they were allergic to were to be avoided for the entire duration of the study.
- Asthma related to non-steroidal anti-inflammatory drug (NSAID).
- Treatment of exacerbation in the 4 weeks prior to randomization.
- Other active lung diseases.
- Medical history of others uncontrolled diseases 3 months prior randomization (eg, infections, coronary heart diseases and metabolic diseases).
- Any history of cancer.
- Abnormal electrocardiogram (ECG), laboratory exams (clinically significant abnormalities), and chest X-ray (CXR).
- Evidence or history of drug or alcohol abuse.
- Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to screening visit.
- Smokers or smoking history of > 10 pack-years.
- Subject that had been treated with investigational drugs over the past 30 days or during the course of the trial.
- Subject had elevated IgE levels for reasons other than allergy.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.
- Conditions
- Asthma
- Being tested
- Omalizumab, Inhaled corticosteroids (ICS), Long-acting beta 2-adrenergic agonist (LABA), Short-acting beta 2-adrenergic agonist (SABA)
- Keywords
- Asthma, anti-immunoglobulin E, omalizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.
Inhaled corticosteroids (ICS)Drug
Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent
Long-acting beta 2-adrenergic agonist (LABA)Drug
Fixed dose of LABA as prescribed prior to study entry
Short-acting beta 2-adrenergic agonist (SABA)Drug
Also called salbutamol, terbutaline
Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab + Conventional Therapy | Active comparator | Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. Receives: Drug: Omalizumab; Drug: Inhaled corticosteroids (ICS); Drug: Long-acting beta 2-adrenergic agonist (LABA); Drug: Short-acting beta 2-adrenergic agonist (SABA) |
| Conventional Therapy | Active comparator | Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. Receives: Drug: Inhaled corticosteroids (ICS); Drug: Long-acting beta 2-adrenergic agonist (LABA); Drug: Short-acting beta 2-adrenergic agonist (SABA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.
Measured: Baseline and Week 20
Secondary outcomes (9)
Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
Measured: Baseline and Week 20
Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
Measured: Baseline and Week 20
The Mean Change From Baseline to the End of Study in AQLQ Domain Score
AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.
The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment.
Measured: Baseline and Week 20
Number of Asthma Exacerbation Episodes Per Participant
For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.
Measured: From Baseline through 20 weeks
Percentage of Participants Using Rescue Medication
When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.
Measured: From Baseline through 20 Weeks
Free Days With no Rescue Medication
When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.
Measured: From Baseline through 20 weeks (140 days)
Mean Number of Puffs of Rescue Medication Taken Per Day
When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.
Measured: From Baseline through 20 Weeks
Physician's Global Assessment of Treatment Effectiveness
At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma
Measured: 20 Weeks
Patient's Global Assessment of Treatment Effectiveness
At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:
Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567476
- Sponsor's protocol ID
- CIGE025ABR01
- Status last verified
- Jun 2011
- First submitted
- 4 Dec 2007
- Last updated
- 30 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
- ClinicalTrials.gov ID
- NCT00567476
- Acronym / sponsor ID
- CIGE025ABR01
- Conditions
- Asthma
- Keywords
- Asthma, anti-immunoglobulin E, omalizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 23 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab + Conventional Therapy | Active comparator | Drug: Omalizumab, Drug: Inhaled corticosteroids (ICS), Drug: Long-acting beta 2-adrenergic agonist (LABA), Drug: Short-acting beta 2-adrenergic agonist (SABA)Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. |
| Conventional Therapy | Active comparator | Drug: Inhaled corticosteroids (ICS), Drug: Long-acting beta 2-adrenergic agonist (LABA), Drug: Short-acting beta 2-adrenergic agonist (SABA)Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 12 to 75 years-old during screening visit.
- Body weight > 20 kg and < 150 kg.
- Daily or persistent asthma symptoms.
- Night symptoms at least once a week.
- Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal value and continuing asthma symptoms.
Key exclusion criteria (22 listed)
- Pregnant, nursing female subjects.
- Female subjects without current acceptable contraceptive method.
- Previous history of allergy or hypersensitivity to omalizumab.
- Subjects with prior treatment with omalizumab.
- Subjects with medical history of psychiatric disorder.
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 |
|---|---|---|
| OmalizumabAlso: XolairOmalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE. | Drug | Omalizumab + Conventional Therapy |
| Inhaled corticosteroids (ICS)Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent | Drug | Conventional Therapy, Omalizumab + Conventional Therapy |
| Long-acting beta 2-adrenergic agonist (LABA)Fixed dose of LABA as prescribed prior to study entry | Drug | Conventional Therapy, Omalizumab + Conventional Therapy |
| Short-acting beta 2-adrenergic agonist (SABA)Also: salbutamol, terbutalineHome use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm. | Drug | Conventional Therapy, Omalizumab + Conventional Therapy |
Primary outcome
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Baseline and Week 20
The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.
9 secondary outcomes
Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
Time frame: Baseline and Week 20
Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
Time frame: Baseline and Week 20
The Mean Change From Baseline to the End of Study in AQLQ Domain Score
Time frame: Baseline and Week 20
Number of Asthma Exacerbation Episodes Per Participant
Time frame: From Baseline through 20 weeks
Percentage of Participants Using Rescue Medication
Time frame: From Baseline through 20 Weeks
Free Days With no Rescue Medication
Time frame: From Baseline through 20 weeks (140 days)
Mean Number of Puffs of Rescue Medication Taken Per Day
Time frame: From Baseline through 20 Weeks
Physician's Global Assessment of Treatment Effectiveness
Time frame: 20 Weeks
Patient's Global Assessment of Treatment Effectiveness
Time frame: 20 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharma study chair
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab, Inhaled corticosteroids (ICS) and Long-acting beta 2-adrenergic agonist (LABA) in people with Asthma, run by Novartis at 1 site in Brazil.
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 11 inclusion and 22 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 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) (time frame: Baseline and Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2011.