Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01000506
Registration number
NCT01000506
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009
Titles & IDs
Public title
Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma
Query!
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma
Query!
Secondary ID [1]
0
0
112997
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DREAM
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Mepolizumab 750
Treatment: Other - Mepolizumab 250
Treatment: Other - Mepolizumab 75
Treatment: Drugs - Placebo saline
Active comparator: Mepolizumab 750mg - Mepolizumab 750mcg i.v. every 4 weeks
Active comparator: Mepolizumab 250mg - Mepolizumab 250mcg i.v. every 4 weeks
Active comparator: Mepolizumab 75mg - Mepolizumab 75mcg i.v. every 4 weeks
Placebo comparator: Placebo - Placebo saline every 4 weeks i.v.
Treatment: Other: Mepolizumab 750
Mepolizumab 750mg every four weeks by i.v.
Treatment: Other: Mepolizumab 250
Mepolizumab 250mg every four weeks by i.v.
Treatment: Other: Mepolizumab 75
Mepolizumab 75mg every four weeks by i.v.
Treatment: Drugs: Placebo saline
Placebo saline every four weeks by i.v.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Clinically Significant Exacerbations of Asthma Per Year
Query!
Assessment method [1]
0
0
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids \[OCS\], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
Query!
Timepoint [1]
0
0
From randomization (Week 0) to Week 52 or early withdrawal (EW)
Query!
Secondary outcome [1]
0
0
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Query!
Assessment method [1]
0
0
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
Query!
Timepoint [1]
0
0
From randomization (Week 0) to Week 52 or EW
Query!
Secondary outcome [2]
0
0
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
Query!
Assessment method [2]
0
0
The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit \[ICU\]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
Query!
Timepoint [2]
0
0
From randomization (Week 0) to Week 52 or EW
Query!
Secondary outcome [3]
0
0
Time to First Exacerbation Requiring Hospitalization or ED Visit
Query!
Assessment method [3]
0
0
Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
Query!
Timepoint [3]
0
0
From randomization (Week 0) to Week 52 or EW
Query!
Secondary outcome [4]
0
0
Number of All Recorded Exacerbations Per Year
Query!
Assessment method [4]
0
0
Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in \>=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.
Query!
Timepoint [4]
0
0
From randomization (Week 0) to Week 52 or EW
Query!
Secondary outcome [5]
0
0
Time to First All Recorded Exacerbation
Query!
Assessment method [5]
0
0
All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).
Query!
Timepoint [5]
0
0
From randomization (Week 0) to Week 52 or EW
Query!
Secondary outcome [6]
0
0
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
Query!
Assessment method [6]
0
0
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Query!
Timepoint [6]
0
0
From Baseline up to Week 52 or EW
Query!
Secondary outcome [7]
0
0
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
Query!
Assessment method [7]
0
0
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve \>=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment
Query!
Timepoint [7]
0
0
From Baseline up to Week 52 or EW
Query!
Secondary outcome [8]
0
0
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
Query!
Assessment method [8]
0
0
The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.
Query!
Timepoint [8]
0
0
From Baseline up to Week 52 or EW
Query!
Eligibility
Key inclusion criteria
* Male or female
* Aged 12 to 65 years inclusive
* Minimum weight 45kg
* Clinical features of severe refractory asthma
* Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
* Using additional controller medication in addition to high dose ICS for at least 12 months
* Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
* Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
* History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
* Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
* ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
* Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
* Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
* Able to give written informed consent
* Able to read, comprehend and write at a sufficient level to complete study materials
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Current smokers or smoking history of >=10 pack years
* Clinically important lung condition other than asthma
* Diagnosis of malignancy or in the process of investigation
* Unstable liver disease
* Churg-Strauss syndrome
* Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
* Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
* Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
* Allergy/intolerance to the excipients in the mepolizumab formulation
* Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
* Pregnant or breastfeeding or planning to become pregnant
* Clinically significant disease which is uncontrolled with standard treatment
* History of alcohol misuse or substance abuse
* Parasitic infestation within previous 6 months
* Known immunodeficiency
* Unable to follow instructions, use the electronic diary or peak flow meter
* Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
* Previous participation in a study of mepolizumab and received study medication within 90 days
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
23/03/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
621
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - New Lambton
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Clayton
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2305 - New Lambton
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Wisconsin
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Mendoza
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Tucuman
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Alberta
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
British Columbia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Quebec
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Región Metro De Santiago
Query!
Country [24]
0
0
Chile
Query!
State/province [24]
0
0
Valparaíso
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Santiago
Query!
Country [26]
0
0
Chile
Query!
State/province [26]
0
0
Talcahuano
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Clamart
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Marseille cedex 20
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Montpellier
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Nantes
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Saint Pierre cedex
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Brandenburg
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Hessen
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Rheinland-Pfalz
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Sachsen-Anhalt
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Schleswig-Holstein
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Berlin
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Bucheon-si,
Query!
Country [39]
0
0
Korea, Republic of
Query!
State/province [39]
0
0
Cheongju, Chungcheongbuk-do
Query!
Country [40]
0
0
Korea, Republic of
Query!
State/province [40]
0
0
Seoul
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Suwon, Kyonggi-do
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Bialystok
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Lodz
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Warszawa
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Wroclaw
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Zawadzkie
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Zgierz
Query!
Country [48]
0
0
Romania
Query!
State/province [48]
0
0
Bucharest
Query!
Country [49]
0
0
Romania
Query!
State/province [49]
0
0
Bucuresti
Query!
Country [50]
0
0
Romania
Query!
State/province [50]
0
0
Iasi
Query!
Country [51]
0
0
Romania
Query!
State/province [51]
0
0
Targu Mures
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
Barnaul
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Chelyabinsk
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Kazan
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Moscow
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saint-Petersburg
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
St. Petersburg
Query!
Country [58]
0
0
Russian Federation
Query!
State/province [58]
0
0
Tomsk
Query!
Country [59]
0
0
Ukraine
Query!
State/province [59]
0
0
Cherkassy
Query!
Country [60]
0
0
Ukraine
Query!
State/province [60]
0
0
Dnipropetrovsk
Query!
Country [61]
0
0
Ukraine
Query!
State/province [61]
0
0
Donetsk
Query!
Country [62]
0
0
Ukraine
Query!
State/province [62]
0
0
Kharkiv
Query!
Country [63]
0
0
Ukraine
Query!
State/province [63]
0
0
Kiev
Query!
Country [64]
0
0
Ukraine
Query!
State/province [64]
0
0
Kyiv
Query!
Country [65]
0
0
Ukraine
Query!
State/province [65]
0
0
Mykolayiv
Query!
Country [66]
0
0
United Kingdom
Query!
State/province [66]
0
0
Leicestershire
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
London
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Manchester
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01000506
Query!
Trial related presentations / publications
Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X. Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26. Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available. Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15. Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16. Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC. Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01000506