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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01691859
Registration number
NCT01691859
Ethics application status
Date submitted
13/09/2012
Date registered
25/09/2012
Date last updated
28/06/2023
Titles & IDs
Public title
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
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Scientific title
MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
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Secondary ID [1]
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2012-001643-51
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Secondary ID [2]
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115666
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab
Experimental: Mepolizumab - Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
Treatment: Drugs: Mepolizumab
100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)
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Assessment method [1]
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AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.
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Timepoint [1]
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Baseline (Week 0) to Week 240
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Secondary outcome [1]
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Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions
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Assessment method [1]
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Systemic and local site reactions following mepolizumab dosing as identified by the investigator and the number of participants who experienced systemic and/or local site reactions are presented. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.
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Timepoint [1]
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Baseline (Week 0) to Week 240
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Secondary outcome [2]
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Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])
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Assessment method [2]
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Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [2]
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Baseline (Week 0) to Week 240
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Secondary outcome [3]
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Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])
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Assessment method [3]
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Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [3]
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Baseline (Week 0) to Week 240
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Secondary outcome [4]
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Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)
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Assessment method [4]
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Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Number of participants with a maximum change from Baseline for QTc(F) and QTc(B) at any time post Baseline are presented. Only those participants who provided ECG data at baseline and post-baseline were analyzed.
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Timepoint [4]
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Baseline (Week 0) to Week 240
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Secondary outcome [5]
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Number of Participants With Clinical Chemistry Data of Potential Clinical Concern
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Assessment method [5]
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Clinical chemistry analytes with laboratory ranges defining values of potential clinical concern included sodium, potassium, calcium, phosphate, serum glucose and alanine aminotransferase. Number of participants with clinical chemistry abnormalities of potential clinical concern anytime post baseline are presented. Only those participants who provided lab data post-baseline were analyzed represented by n=X in the category titles.
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Timepoint [5]
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Baseline (Week 0) to Week 240
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Secondary outcome [6]
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Number of Participants With Hematology Data of Potential Clinical Concern
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Assessment method [6]
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Hematology parameters with laboratory ranges defining values of potential clinical concern included hemoglobin, hematocrit, platelet count, white blood cell count. Number of participants with clinical hematology abnormalities of potential clinical concern anytime post baseline are presented, which only included participants with low hemoglobin values. Only those participants who provided lab data post-baseline were analyzed.
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Timepoint [6]
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Baseline (Week 0) to Week 240
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Secondary outcome [7]
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Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure
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Assessment method [7]
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Vital signs included sitting pulse rate and sitting blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [7]
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Baseline (Week 0) to Week 240
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Secondary outcome [8]
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Mean Change From Baseline in Vital Signs-Sitting Pulse Rate
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Assessment method [8]
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Vital signs included sitting pulse rate and blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [8]
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Baseline (Week 0) to Week 240
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Secondary outcome [9]
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Annualized Rate of On-treatment Exacerbations
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Assessment method [9]
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Exacerbations were defined as worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department visits. Data is presented as mean which is exacerbation rate/year. Exacerbation data are performed using a negative binomial model with covariates of region, annualized rate of exacerbations in the interval between MEA112997 and MEA115666 (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.
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Timepoint [9]
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Baseline (Week 0) to Week 240
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Secondary outcome [10]
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Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score
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Assessment method [10]
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The ACQ-5 is a five-item questionnaire, which was developed as a measure of participant' asthma control that was completed by the participant. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The ACQ consists of 5 questions that are scored on a 7 point scale from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ score was derived as mean of five questions: ACQ score = Question 1 (Q1)+Q2+Q3+Q4+Q5 divided by 5 where Q1, Q2,... Q5 are the scores of Q1, Q2, ..., Q5, respectively. The total score ranged from zero (no impairment/limitation) which indicated best condition to six (total impairment/ limitation) which indicated worst asthma. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [10]
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Baseline (Week 0) to Week 240
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Secondary outcome [11]
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Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [11]
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FEV1 is forced expiratory volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. FEV1 was measured by clinic spirometry. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [11]
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Baseline (Week 0) to Week 240
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Secondary outcome [12]
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Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)
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Assessment method [12]
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Immunogenicity testing included two types of assays: a binding antibody assay (anti-drug antibody; ADA) and a neutralizing antibody (NAb) assay for participants who were tested positive in the ADA assay. Blood samples were collected for the determination of anti-mepolizumab antibodies, just prior to administration of mepolizumab. Samples that test positive for anti-mepolizumab antibodies were further tested for the presence of neutralizing antibody. Number of participants with positive highest value post-Baseline have been presented. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
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Timepoint [12]
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Baseline (Week 0) to Week 240
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Secondary outcome [13]
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Number of Participants Who Withdrew Due to Lack of Efficacy
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Assessment method [13]
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Lack of efficacy referred to failure of expected pharmacological action of Mepolizumab. Number of participants who withdrew due to lack of efficacy are presented.
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Timepoint [13]
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Baseline (Week 0) to Week 240
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Secondary outcome [14]
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Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations
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Assessment method [14]
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AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.
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Timepoint [14]
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Baseline (Week 0) to Week 240
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Secondary outcome [15]
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Number of Participants Who Withdrew Due to AE
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Assessment method [15]
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AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants who withdrew due to AE are presented.
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Timepoint [15]
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Baseline (Week 0) to Week 240
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Eligibility
Key inclusion criteria
- Informed Consent.
- MEA112997 Study Participation: Received at least 2 doses of double-blind
investigational product during the MEA112997 trial.
- MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have
had a positive risk: benefit ratio.
- Currently being treated with a controller medication and the subject has been on a
controller medication for the past 12 weeks.
- Male or Eligible Female Subjects. To be eligible for entry into the study, females of
childbearing potential must commit to consistent and correct use of an acceptable
method of birth control for the duration of the trial and for 4 months after the last
study drug administration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Hypersensitivity related to mepolizumab.
- Clinically significant change in health status since completing participation in the
MEA112997 trial.
- A current malignancy or previous history of cancer in remission for less than 12
months prior to screening.
- For those subjects who had a SAE in MEA112997 that was assessed as possibly related to
mepolizumab by the investigator.
- Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they
plan to become pregnant during the time of study participation.
- Screening ECG which has a clinically significant abnormality.
- Received Xolair (omalizumab) within the past 130 days.
- Participated in a clinical trial within the past 30 days or have received
investigational medication within five terminal half-lives of Screen Visit, whichever
is longer.
- Current smokers.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/09/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2017
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Sample size
Target
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Accrual to date
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Final
347
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - New Lambton
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Recruitment hospital [2]
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GSK Investigational Site - Adelaide
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Recruitment hospital [3]
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GSK Investigational Site - Clayton
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Recruitment hospital [4]
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GSK Investigational Site - Melbourne
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Recruitment hospital [5]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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State/province [3]
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Connecticut
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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State/province [11]
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Ciudad Autónoma de Buenos Aires
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Country [12]
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Argentina
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State/province [12]
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Mendoza
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Canada
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State/province [13]
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Alberta
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Country [14]
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Canada
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State/province [14]
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British Columbia
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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Canada
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State/province [16]
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Quebec
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Country [17]
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Chile
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State/province [17]
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Región Metro De Santiago
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0
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Chile
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State/province [18]
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Valparaíso
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0
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Chile
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Santiago
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Chile
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State/province [20]
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Talcahuano
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France
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State/province [21]
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Le Kremlin-Bicêtre Cedex
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France
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State/province [22]
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Marseille cedex 20
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Country [23]
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France
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State/province [23]
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Montpellier cedex 5
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Country [24]
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France
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State/province [24]
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Saint Pierre cedex
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Germany
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State/province [25]
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Brandenburg
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0
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Germany
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State/province [26]
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Hessen
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Germany
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State/province [27]
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Rheinland-Pfalz
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Country [28]
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Germany
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State/province [28]
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Schleswig-Holstein
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Germany
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State/province [29]
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Berlin
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Germany
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State/province [30]
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Magdeburg
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Korea, Republic of
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State/province [31]
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Cheongju, Chungcheongbuk-do
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Korea, Republic of
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State/province [32]
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Suwon, Kyonggi-do
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Poland
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State/province [33]
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Lodz
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Poland
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State/province [34]
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Wroclaw
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Romania
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Bucharest
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Romania
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Iasi
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Romania
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State/province [37]
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Targu Mures
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0
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Russian Federation
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State/province [38]
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Barnaul
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Russian Federation
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State/province [39]
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Chelyabinsk
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Russian Federation
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State/province [40]
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Kazan
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Russian Federation
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State/province [41]
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Moscow
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Russian Federation
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State/province [42]
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Saint-Petersburg
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Russian Federation
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State/province [43]
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St'Petersburg
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Ukraine
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Dnipropetrovsk
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0
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Ukraine
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Donetsk
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0
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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State/province [48]
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Kyiv
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Country [49]
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United Kingdom
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State/province [49]
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Leicestershire
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United Kingdom
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London
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0
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United Kingdom
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Manchester
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Country [52]
0
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United Kingdom
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State/province [52]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab
administered subcutaneously (SC) in addition to standard of care in subjects who participated
in the MEA112997 study. At each clinic visit, adverse events will be assessed and
exacerbations will also be reviewed.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01691859
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Trial related presentations / publications
Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
0
0
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Phone
0
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Fax
0
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Email
0
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Contact person for public queries
Name
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Address
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Country
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Phone
0
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Fax
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Email
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01691859
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