AzTrials
AzTrials

AsthmaPhase 3NCT03562195

A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

A Phase 3 study testing Mepolizumab 100 milligrams and Salbutamol in people with Asthma, run by GlaxoSmithKline at 42 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Mepolizumab 100 milligrams and Salbutamol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
42 sitesChina
Study dates
29 Aug 2018to 7 Sep 2022
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects who will be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
  • Subjects with at least 12 years of age at Visit 0 and a minimum weight of 40 kilograms.
  • Persistent airflow obstruction as indicated by: For subjects >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80 percent predicted (National Health and Nutrition Examination Survey [NHANES] III).;For subjects 12 to 17 years of age at Visit 1: A pre-bronchodilator FEV1 <90 percent predicted (NHANES III) recorded at Visit 1 or FEV1: Forced vital capacity (FVC) ratio <0.8 recorded at Visit 1.
  • Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomization Criteria 1 (Documented peripheral blood eosinophil count of >=300 cells per microliters that is related to asthma in the past 12 months prior to Visit 1 or a peripheral blood eosinophil count of >=150 cells per microliters at Visit 1 that is related to asthma).
  • Regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1, of which at least 9 months accumulated documented is required, the 3 months prior to Visit 1 is mandatory. With or without maintenance oral corticosteroids (OCS). ICS dose must be >=500 microgram per day fluticasone propionate (FP) or equivalent daily (for ICS/long-acting beta-2-agonists combination preparations, Seretide 50/250 micrograms twice daily and above or equivalent will meet this ICS criteria). (Maintenance OCS is defined as a prescribed regimen of a minimum average daily dose of prednisone 5 milligrams [or equivalent]).
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months. (Example given [e.g.], long-acting beta-2-agonist, leukotriene receptor antagonist [LTRA], or theophylline).
Show all 9Show fewer
  • Previously confirmed history of two or more exacerbations requiring treatment with systemic corticosteroid (intramuscular [IM], intravenous, or oral), in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance corticosteroid, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose for at least 3 days is required.
  • A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1 percent, during the intervention period and for at least 4 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test before the first dose of study intervention. If urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. Follicle-stimulating hormone will be assessed to confirm child-bearing status as needed in non WOCBP.

Who cannot join

  • Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = (number of cigarettes per day/20) x number of years smoked). A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1.
  • Presence of a known pre-existing, clinically significant lung condition other than asthma, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. This includes current bacterial or viral infection of the upper or lower respiratory tract, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. Clinically Significant is defined as any disease/condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • A chest X-ray that reveals evidence of clinically significant abnormalities not believed to be due to the presence of asthma.
  • Bronchial Thermoplasty and Radiotherapy are excluded for 12 months prior to visit 1 and throughout the study.
  • A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded).
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or cirrhosis. Subjects with ALT >2 times Upper Limit of Normal (ULN), bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
Show all 23Show fewer
  • Subjects who have known, pre-existing severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: known ejection fraction of <30 percent or severe heart failure meeting New York Heart Association Class IV classification or hospitalized in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III or angina diagnosed less than 3 months prior to Visit 1 or at Visit 1.
  • QT interval corrected by Fridericia's formula (QTc[F]) >450 milliseconds (msec) or QTc(F) >480 msec for subjects with Bundle Branch Block at Visit 1 is exclusive.
  • Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment. Current malignancy except for basal and squamous skin cancer.
  • Subjects with other conditions that could lead to elevated eosinophils such as Hypereosiniophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
  • Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also excluded.
  • A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1. Alcohol abuse is defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit was equivalent to a half-pint (220 milliliters) of beer or one (25 milliliters) measure of spirits or one glass (125 milliliters) of wine.
  • A known immunodeficiency (e.g., human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Subjects who have received omalizumab (Xolair) within 130 days of Visit 1.
  • Subjects who have received any monoclonal antibodies (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
  • Use of herbals within 7 days prior to visit 1, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to visit 1 (this also includes investigational formulations of marketed products).
  • Subjects with allergy/intolerance to a monoclonal antibody or biologic.
  • Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
  • Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
  • Previously participated in any study with mepolizumab and received investigational product (including placebo).
  • A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. Re-screening of subjects will be allowed only upon approval by the medical monitor.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • GSK Investigational Site

    Beijing, 100044

  • GSK Investigational Site

    Beijing, 100144

  • GSK Investigational Site

    Beijing, 100191

  • GSK Investigational Site

    Changchun, Jilin, 130021

  • GSK Investigational Site

    Changchun, Jilin, 130041

  • GSK Investigational Site

    Changsha, 410013

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Fuzhou, Fujian, 350001

  • GSK Investigational Site

    Guangzhou, Guangdong, 510080

  • GSK Investigational Site

    Guangzhou, Guangdong, 510120

  • GSK Investigational Site

    Guangzhou, Guangdong, 510150

  • GSK Investigational Site

    Guangzhou, Guangdong, 510630

  • GSK Investigational Site

    Guangzhou, 511400

  • GSK Investigational Site

    Guiyang, Guizhou, 550002

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310006

  • GSK Investigational Site

    Hangzhou, 310005

  • GSK Investigational Site

    Hengyang, Hunan, 421000

  • GSK Investigational Site

    Hohhot, Inner Mongolia, 010017

  • GSK Investigational Site

    Hohhot, Inner Mongolia, 010050

  • GSK Investigational Site

    Jinan, Shandong, 250012

  • GSK Investigational Site

    Nanjing, Jiangsu, 210006

  • GSK Investigational Site

    Qingdao, Shandong, 266071

  • GSK Investigational Site

    Shanghai, 200000

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200233

  • GSK Investigational Site

    Shanghai, 200433

  • GSK Investigational Site

    Shenyang, Liaoning, 110004

  • GSK Investigational Site

    Shenyang, Liaoning, 110015

  • GSK Investigational Site

    Shenzhen, Guangdong, 518020

  • GSK Investigational Site

    Shijiazhuang, Hebei, 050000

  • GSK Investigational Site

    Suzhou, 215004

  • GSK Investigational Site

    Taiyuan, Shanxi, 030000

  • GSK Investigational Site

    Tianjin, 300052

  • GSK Investigational Site

    Tianjin, 300211

  • GSK Investigational Site

    Ürümqi, Xinjiang, 830054

  • GSK Investigational Site

    Wenzhou, Zhejiang, 323027

  • GSK Investigational Site

    Wuhan, Hubei, 430022

  • GSK Investigational Site

    Wuxi, Jiangsu, 214023

  • GSK Investigational Site

    Yinchuan, Ningxia, 750001

  • GSK Investigational Site

    Zhanjiang, Guangdong, 524001

  • GSK Investigational Site

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Randomized, Double Blind, Parallel Group Study of the Efficacy and Safety of Mepolizumab as Adjunctive Therapy in Patients With Severe Asthma With Eosinophilic Inflammation

Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. There is a significant unmet medical need to provide better treatment options for this segment of the asthma population. Thus, this study is designed to evaluate the efficacy and safety of mepolizumab in Chinese severe asthmatic subjects with eosinophilic inflammation. A total number of 300 subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy. The maximum study duration will be 56 weeks.

Conditions
Asthma
Being tested
Mepolizumab 100 milligrams, Placebo, Salbutamol
Keywords
Eosinophilic inflammation, Mepolizumab, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mepolizumab 100 milligramsDrug

    Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use.

  • PlaceboDrug

    Placebo will be given as 0.9 percent sodium chloride solution.

  • SalbutamolDrug

    Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.

Study groups in NCT03562195
Study groupRoleWhat they receive
Mepolizumab 100mgExperimentalParticipants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis.
Receives: Drug: Mepolizumab 100 milligrams; Drug: Salbutamol
PlaceboPlacebo comparatorParticipants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis
Receives: Drug: Placebo; Drug: Salbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Clinically Significant Exacerbations of Asthma

    Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

    Measured: Up to Week 52

Secondary outcomes (18)

  1. Percent Probability of First Clinically Significant Exacerbations at Week 16, Week 32, and Week 52

    Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. Time to first clinically significant exacerbation was analyzed using Kaplan-Meier estimates and expressed in terms of probability.

    Measured: Week 16, 32 and 52

  2. Mean Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) at Week 52

    The SGRQ Questionnaire is a well-established, self-completed tool, with 50 questions comprising three domains: Symptoms, Activity, and Impacts scores (each ranging from 0 to 100; where higher score indicates worst outcome). SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The SGRQ total score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Analysis was performed using mixed model repeated measures with covariates of baseline, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.

    Measured: Baseline and Week 52

  3. Number of Participants With Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or Emergency Department (ED) Visits

    An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. The number of exacerbations requiring hospitalization including incubation and admittance to an Intensive care unit (ICU) or ED visits were evaluated. Analysis of number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable. The data for participants with 0, 1, 2 and 3 exacerbations requiring hospitalization (including intubation and admittance to an ICU) or ED visits are summarized.

    Measured: Up to Week 52

  4. Number of Participants With Clinically Significant Exacerbations Requiring Hospitalization

    An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. Analysis of number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable. The summary data for participants with 0, 1, 2 and 3 exacerbations requiring hospitalization are summarized.

    Measured: Up to Week 52

  5. Mean Change From Baseline in Clinic Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 52

    FEV1 is the volume of air that can be forced out in one second after taking a deep breath. Prebronchodilator FEV1 were measured via spirometer at Baseline and Week 52. Analysis was performed using mixed model repeated measures with covariates of baseline, 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.

    Measured: Baseline and Week 52

  6. Number of Participants With Adverse Events (AEs) Including Systemic (i.e., Allergic [Type I Hypersensitivity] and Other Systemic) and Injection Site Reactions

    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. Systemic reactions and local injection site reactions are adverse events of special interest (AESIs).

    Measured: Up to Week 52

  7. Change From Baseline in Platelets Count

    Blood samples was collected for the assessment of change from baseline in hematology parameter Platelets count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  8. Change From Baseline in Erythrocytes Count

    Blood samples was collected for the assessment of change from baseline in hematology parameter Erythrocytes count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  9. Change From Baseline in Hematocrit

    Blood samples was collected for the assessment of change from baseline in hematology parameter Hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  10. Percent Change From Baseline in Mean White Blood Cell (WBC) Count With Differential (Neutrophils, Lymphocytes, Monocytes. Eosinophils and Basophils)

    Blood samples was collected for the assessment of change from baseline in WBC) count with differential (neutrophils, lymphocytes, monocytes. eosinophils and basophils). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline and Week 52

  11. Change From Baseline in Alkaline Phosphatase

    Blood samples was collected for the assessment of change from baseline in clinical parameter Alkaline Phosphatase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  12. Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase

    Blood samples was collected for the assessment of change from baseline in clinical parameter Alanine Aminotransferase, Aspartate Aminotransferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  13. Change From Baseline in Albumin and Total Protein

    Blood samples was collected for the assessment of change from baseline in clinical parameter albumin, total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  14. Change From Baseline in Clinical Chemistry Parameters

    Blood samples was collected for the assessment of change from baseline in clinical parameter including total and direct bilirubin, creatinine, glucose, calcium, sodium, potassium, urea. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.

    Measured: Baseline and Week 52

  15. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were measured in a sitting position after 5 minutes rest. The normal range for SBP is 90-140 mmHg and DBP is 60-90 millimeters of mercury (mmHg).

    Measured: Baseline and Week 52

  16. Mean Change From Baseline in Pulse Rate

    Pulse rate measurement were measured in a sitting position after 5 minutes rest.

    Measured: Baseline and Week 52

  17. Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings

    12-Lead electrocardiogram (ECG) measurements were obtained after the participants had rested in the supine position for 5 minutes. Clinically significant abnormal findings are based on the judgement of the investigator.

    Measured: Up to Week 52

  18. Number of Participants With Positive Anti-Mepolizumab Antibody

    Blood samples were collected for detection of binding and neutralizing anti-mepolizumab antibodies. Samples with a positive screening result continued for confirmation analysis. Samples with a positive confirmation analysis were considered positive for mepolizumab Anti-drug antibody (ADA).

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start29 Aug 2018
  3. Primary completion7 Sep 2022
  4. Study completion7 Sep 2022

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy during the treatment period.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562195
Sponsor's protocol ID
201536
Status last verified
Apr 2024
First submitted
22 May 2018
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

  • Chen R, Wei L, Dai Y, Wang Z, Yang D, Jin M, Xiong C, Li T, Hu S, Song J, Chan R, Kumar S, Abdelkarim A, Zhong N. Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial. ERJ Open Res. 2024 May 20;10(3):00750-2023. doi: 10.1183/23120541.00750-2023. eCollection 2024 May.

    PubMed 38770009

  • Chen R, Wei L, Jin M, Jiang Y, Gao X, Zhao L, Wang L, Liu S, Howarth P, Xiong C, Huang J, Liang P, Hu X, Zhong N. Add-on mepolizumab in patients with severe asthma on medium-dose inhaled corticosteroids. ERJ Open Res. 2026 Aug 17;12(4):01652-2025. doi: 10.1183/23120541.01652-2025. eCollection 2026 Jul.

    PubMed 42609784

  • Shi C, Wang Y, Tan C, Zeng X, Liu Q. Cost-effectiveness analysis of mepolizumab among patients with severe asthma from the Chinese societal perspective. PLoS One. 2026 May 13;21(5):e0348955. doi: 10.1371/journal.pone.0348955. eCollection 2026.

    PubMed 42127033

  • Chen R, Dai Y, Yang D, Liu C, Han W, Gu W, Cao J, Zhou Q, Howarth P, Weng S, Xiong C, Huang J, Liang P, Zhong N; 201536 Study Group. Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Allergy Asthma Immunol Res. 2025 Jul;17(4):473-485. doi: 10.4168/aair.2025.17.4.473.

    PubMed 40736776

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab 100 milligrams and Salbutamol in people with Asthma, run by GlaxoSmithKline at 42 sites in China.

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 9 inclusion and 23 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Sep 2024). 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 Clinically Significant Exacerbations of Asthma (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562195, which also lists 4 linked publications.

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 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in