Severe IgE-mediated AsthmaPhase 4MEXICNCT01912872
Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
A Phase 4 study testing Omalizumab, Budesonide and Formoterol in people with Severe IgE-mediated Asthma, run by Novartis Pharmaceuticals at 21 sites in Mexico.
Trial summary
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids. Read more about this study
- Who is it for?
- Ages 6 to 55 years
- Conditions the study is for
- Severe IgE-mediated Asthma
- What is being tested?
- Omalizumab, Budesonide and Formoterol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 21 sitesMexico
- Study dates
- 11 Nov 2013to 8 Jan 2016
- 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 6 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female between 6 and 55 years old. If female, participant of childbearing potential must use a safe and efficacious birth control method.
- Asthma is considered as not well-controlled if participant has 3 or more of the following conditions:
- Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
- One or more night-time awakenings over the last 4 weeks.
- Any limitation of age-appropriated habitual activities.
- Need of rescue medication (short acting β2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutive weeks within the 4 weeks before selection.
Show all 25Show fewer
- Peak expiratory flow (PEF) or VEF1 <80% predicted or personal best (if known) this is not mandatory for pediatric participants (under 18 years old).
- Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
- At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (β2-agonists and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20 minutes).
- Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
- IgE total concentration ranging from 30 to 1500 UI/ml.
- Body weight between 20 to 150 kg Exclusion Criteria
- Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential.
- Currently smokers or history of smoking 10 or more packs per year.
- Ex-smokers with a history of more than 10 years of smoking. As an exception, a participant with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%.
- Active lung disease other than asthma.
- Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit.
- Use of omalizumab during the 4 months prior to de screening visit.
- History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled.
- History of hepatic, neurologic, oncologic or autoimmune disease.
- Participant under suspicion of having cancer.
- Participants with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin.
- Hypersensitivity to omalizumab or its excipients.
- Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant.
- Underage participant or any participant under vulnerable conditions who does not live with their parents or legal guardian.
Who cannot join
None listed.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Mexico21 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44500
Novartis Investigative Site
Guadalajara, Jalisco, 44600
Novartis Investigative Site
Guadalajara, Jalisco, 44620
Novartis Investigative Site
Guadalajara, Jalisco, 44690
Novartis Investigative Site
Guadaljara, Jalisco, 44500
Novartis Investigative Site
Mérida, Yucatán, 97070
Novartis Investigative Site
México, Edo. de México, 53910
Novartis Investigative Site
Mexico City, Mexico City, 03020
Novartis Investigative Site
Mexico City, Mexico City, 03100
Novartis Investigative Site
Mexico City, Mexico City, 04700
Novartis Investigative Site
Mexico City, Mexico City, 04980
Novartis Investigative Site
Mexico City, Mexico City, 06090
Novartis Investigative Site
Mexico City, Mexico City, 06760
Novartis Investigative Site
Mexico City, Mexico City, 14000
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Monterrey, Nuevo León, 64020
Novartis Investigative Site
Monterrey, Nuevo León, 64718
Novartis Investigative Site
Nezahualcóyotl, State of Mexico, 57730
Novartis Investigative Site
Pachuca, Hidalgo, 42090
Novartis Investigative Site
Tepic, Nayarit, 63000
Novartis Investigative Site
Tuxtla Gutiérrez, Chiapas, 29030
About this study
Official title: Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.
Read the detailed description
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.
The study comprised 4 phases:
During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.
During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.
During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).
- Conditions
- Severe IgE-mediated Asthma
- Being tested
- Omalizumab, Budesonide, Formoterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Subcutaneous injection dose according to the IgE level and body weight.
BudesonideDrug
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
FormoterolDrug
Formoterol 12ug tablets taken orally according to maximum daily dose.
BudesonideDrug
Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
FormoterolDrug
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab + budesonide and formoterol | Experimental | Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose. Receives: Drug: Omalizumab; Drug: Budesonide; Drug: Formoterol |
| Budesonide and formoterol | Active comparator | Participants will receive budesonide and formoterol according to maximum daily dose. Receives: Drug: Budesonide; Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Prescribed Budesonide Dose (μg) at Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Measured: Baseline
Secondary outcomes (8)
Number of Hospital Admissions Due to Asthma Exacerbation
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
Measured: 12 month treatment duration
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
Measured: 12 month treatment duration
Control of Asthma Symptoms- Daytime Symptoms
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Measured: 12 month treatment duration
Control of Asthma Symptoms
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Measured: 12 month treatment duration
Control of Asthma Symptoms- Rescue Medication Use
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Measured: 12 month treatment duration
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
Number of days of concomitant medications use reported by participants at all visits via diaries.
Measured: 12 month treatment duration
Asthma Control Questionnaire (ACQ) at Baseline
The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.
Measured: Baseline
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ[S]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study start11 Nov 2013
- Primary completion6 Aug 2015
- Study completion8 Jan 2016
Why it stopped: Termination was due to identified errors in data management handling after an internal audit by the sponsor performed by third party.
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 Severe IgE-mediated AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912872
- Sponsor's protocol ID
- CIGE025AMX02
- Acronym
- MEXIC
- Status last verified
- Jun 2019
- First submitted
- 29 Jul 2013
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.
- ClinicalTrials.gov ID
- NCT01912872
- Acronym / sponsor ID
- MEXIC / CIGE025AMX02
- Conditions
- Severe IgE-mediated Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination was due to identified errors in data management handling after an internal audit by the sponsor performed by third party.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 6 Aug 2015 (actual)
- Study completion
- 8 Jan 2016 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.
Detailed description
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.
The study comprised 4 phases:
During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.
During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.
During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab + budesonide and formoterol | Experimental | Drug: Omalizumab, Drug: Budesonide, Drug: FormoterolParticipants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose. |
| Budesonide and formoterol | Active comparator | Drug: Budesonide, Drug: FormoterolParticipants will receive budesonide and formoterol according to maximum daily dose. |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Male and female between 6 and 55 years old. If female, participant of childbearing potential must use a safe and efficacious birth control method.
- Asthma is considered as not well-controlled if participant has 3 or more of the following conditions:
- Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
- At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (β2-agonists and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20 minutes).
- Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OmalizumabSubcutaneous injection dose according to the IgE level and body weight. | Drug | Omalizumab + budesonide and formoterol |
| BudesonideBudesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose. | Drug | Budesonide and formoterol, Omalizumab + budesonide and formoterol |
| FormoterolFormoterol 12ug tablets taken orally according to maximum daily dose. | Drug | Budesonide and formoterol, Omalizumab + budesonide and formoterol |
| BudesonideBudesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information. | Drug | Budesonide and formoterol, Omalizumab + budesonide and formoterol |
| FormoterolFormoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information. | Drug | Budesonide and formoterol |
Primary outcome
The Mean Prescribed Budesonide Dose (μg) at Baseline
Time frame: Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
8 secondary outcomes
Number of Hospital Admissions Due to Asthma Exacerbation
Time frame: 12 month treatment duration
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Time frame: 12 month treatment duration
Control of Asthma Symptoms- Daytime Symptoms
Time frame: 12 month treatment duration
Control of Asthma Symptoms
Time frame: 12 month treatment duration
Control of Asthma Symptoms- Rescue Medication Use
Time frame: 12 month treatment duration
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
Time frame: 12 month treatment duration
Asthma Control Questionnaire (ACQ) at Baseline
Time frame: Baseline
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Pharmaceuticals study director
Novartis Pharmaceuticals
21 sites 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, Budesonide and Formoterol in people with Severe IgE-mediated Asthma, run by Novartis Pharmaceuticals at 21 sites in Mexico.
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 25 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Mexico. 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 2 Jul 2019). 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 Prescribed Budesonide Dose (μg) at Baseline (time frame: Baseline). 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 2 Jul 2019.