AsthmaPhase 4EXACTNCT00096954
A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
A Phase 4 study testing omalizumab (Xolair) in people with Asthma, run by Genentech, Inc..
Trial summary
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled… 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 (Xolair)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Sep 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
- Have a documented history of asthma as well as evidence of ≥ 12% reversibility of FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol administration at any time during the preceding 24 months; 2) Documentation of ≥ 12% improvement in FEV1 with two separate measurements obtained within a 4-week period surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration of ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening
- Have baseline FEV1 ≥ 80% predicted normal value prior to randomization
- Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro radioallergosorbent test (RAST(R)) or ImmunoCap(R) to one relevant perennial aeroallergen such as cat or house dust mites documented within the previous year
- Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to the screening visit
- During the 4-week run-in period prior to randomization, demonstrate evidence of inadequate asthma symptom control despite inhaled corticosteroids with or without other controller asthma medications (e.g., LABA, LTRA, immunotherapy). Inadequate asthma symptom control is defined as at least one of the following reported on the subject diary card during the 4-week run-in period: Daytime asthma symptoms as a score of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as a day with no symptoms) and a mean symptom score of ≥ 1.5 (mean will be calculated based on only data supplied; missing values will not be considered) or Nighttime awakening because of asthma symptoms (more than 4 times during the 4-week run-in period)
- Meet the study drug-dosing table eligibility criteria (serum baseline IgE level ≥ 30 to ≤ 1300 IU/mL and body weight ≥ 20 to ≤ 150 kg)
- If a female of childbearing potential, use an effective method of contraception (in the opinion of the investigator) to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study
Who cannot join
- Have received chronic systemic corticosteroids (oral or intravenous) within 3 months or have received a burst of oral corticosteroids within the last 2 weeks prior to screening
- Have received Xolair therapy at any time within 12 months prior to screening
- Are pregnant or lactating
- Have a known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
- Have a lifetime history of smoking > 10-pack years
- Have active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease)
Show all 10Show fewer
- Have a history of upper respiratory infection or lower respiratory infection within the 30 days prior to randomization
- Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
- Have taken immunosuppressants or other investigational drugs within the 30 days prior to screening
- Have a significant medical illness other than asthma
About this study
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).
- Conditions
- Asthma
- Being tested
- omalizumab (Xolair), placebo
- Keywords
- Omalizumab (Xolair), Atopic Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumab (Xolair)Drug
Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
placeboDrug
The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks. Receives: Drug: omalizumab (Xolair) |
| Placebo | Placebo comparator | Placebo administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Asthma Exacerbations Over the 24 Week Treatment Period
A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group.
Measured: Start of treatment to 24 weeks
Secondary outcomes (3)
Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period
The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
Measured: Start of treatment to 24 weeks
Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24
The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).
The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).
Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).
A negative change from baseline score indicates improvement.
Measured: Baseline and 24 weeks
Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.
The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startFeb 2006
- Primary completionSep 2010
- Study completionSep 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Rosen, MD, PhD, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096954
- Sponsor's protocol ID
- Q2982g
- Acronym
- EXACT
- Status last verified
- May 2017
- First submitted
- 17 Nov 2004
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
- ClinicalTrials.gov ID
- NCT00096954
- Acronym / sponsor ID
- EXACT / Q2982g
- Conditions
- Asthma
- Keywords
- Omalizumab (Xolair), Atopic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Nov 2004 (estimated)
- Results
- Posted 8 Dec 2011
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, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: omalizumab (Xolair)Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks. |
| Placebo | Placebo comparator | Drug: placeboPlacebo administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have a documented history of asthma as well as evidence of ≥ 12% reversibility of FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol administration at any time during the preceding 24 months; 2) Documentation of ≥ 12% improvement in FEV1 with two separate measurements obtained within a 4-week period surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration of ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening
- Have baseline FEV1 ≥ 80% predicted normal value prior to randomization
- Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro radioallergosorbent test (RAST(R)) or ImmunoCap(R) to one relevant perennial aeroallergen such as cat or house dust mites documented within the previous year
- Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to the screening visit
- During the 4-week run-in period prior to randomization, demonstrate evidence of inadequate asthma symptom control despite inhaled corticosteroids with or without other controller asthma medications (e.g., LABA, LTRA, immunotherapy). Inadequate asthma symptom control is defined as at least one of the following reported on the subject diary card during the 4-week run-in period: Daytime asthma symptoms as a score of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as a day with no symptoms) and a mean symptom score of ≥ 1.5 (mean will be calculated based on only data supplied; missing values will not be considered) or Nighttime awakening because of asthma symptoms (more than 4 times during the 4-week run-in period)
Key exclusion criteria (10 listed)
- Have received chronic systemic corticosteroids (oral or intravenous) within 3 months or have received a burst of oral corticosteroids within the last 2 weeks prior to screening
- Have received Xolair therapy at any time within 12 months prior to screening
- Are pregnant or lactating
- Have a known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
- Have a lifetime history of smoking > 10-pack years
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 |
|---|---|---|
| omalizumab (Xolair)Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site. | Drug | Omalizumab |
| placeboThe dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks. | Drug | Placebo |
Primary outcome
Rate of Asthma Exacerbations Over the 24 Week Treatment Period
Time frame: Start of treatment to 24 weeks
A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days. The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group.
3 secondary outcomes
Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period
Time frame: Start of treatment to 24 weeks
Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24
Time frame: Baseline and 24 weeks
Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Karin Rosen, MD, PhD study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omalizumab (Xolair) 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 10 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 14 Jun 2017. 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. Some participants in this study may receive a placebo. 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 8 Dec 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?
Rate of Asthma Exacerbations Over the 24 Week Treatment Period (time frame: Start of treatment to 24 weeks). 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 14 Jun 2017.