A Phase 4 interventional study of Mepolizumab and Salbutamol in Asthma, sponsored by GlaxoSmithKline. Completed at 14 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin- 5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian participants aged 18 years or above with severe eosinophilic asthma. After the first dose of mepolizumab, participants will receive 5 more doses of mepolizumab at 4 weekly intervals. Following the last dose of mepolizumab, the end of the study Visit will occur 4 weeks later. During the treatment period, OCS use and dose adjustment in participants will be as per the investigator's discretion and clinical practice.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 100 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Treatment Period Criteria
Exclusion Criteria:
Treatment Period Criteria
Participants with severe eosinophilic asthma will receive Mepolizumab 100 mg subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
Drug: Mepolizumab · Drug: Salbutamol
Mepolizumab will be available as a lyophilized cake in sterile vials and will be reconstituted with sterile water for injection, just prior to use.
Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence that, at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as non-serious adverse events. Number of participants with SAEs and common (greater than equal to \[\>=\] 3 percent \[%\]) non-SAEs were reported.
Time frame: Up to Week 24
Number of Participants With Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were adverse events associated with the identified and potential risks of mepolizumab. AESIs were systemic/ local site reactions, all infections (Infections from Infections and infestations System Organ Class \[SOC\]), opportunistic infections, neoplasm, malignancies, cardiac disorders and serious cardiac, vascular and thromboembolic (CVT) events.
Time frame: Up to Week 24
Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])
Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Exacerbations were treated per the investigator's clinical practice protocol with the use of oral or parenteral corticosteroids. Clinically significant exacerbations were recorded in the electronic case report form (eCRF) by the Investigator or designee were verified using data from the electronic Diary. Number of participants with clinically significant exacerbations were reported.
Time frame: Up to Week 24
Number of Participants With Exacerbations Requiring Hospitalization or ED Visits
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Number of participants with exacerbations requiring hospitalization or ED visits were reported.
Time frame: Up to Week 24
Number of Participants With Exacerbations Requiring Hospitalization
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization. Number of participants with exacerbations requiring hospitalization were reported.
Time frame: Up to Week 24
Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
Time frame: Baseline (Weeks -2 to -1) and Week 24
Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in post-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
Time frame: Baseline (Weeks -2 to -1) and Week 24
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24
The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. The five questions (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms. The response options for all these questions consists of a zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-5 score is calculated as the mean of these 5 item responses and ranges from scores 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline was calculated as the value at Week 24 minus the Baseline value.
Time frame: Baseline (Weeks -2 to -1) and Week 24
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24
PEF was defined as the maximum speed of expiration of a participant, measured with electronic peak flow meter. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Weeks -2 to -1) and Weeks 21 to 24
This study evaluated the safety and efficacy of Mepolizumab in participants with severe eosinophilic asthma.
| Milestone | Mepolizumab 100 mg SC |
|---|---|
| Started | 100 |
| Completed | 90 |
| Not completed | 10 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Physician decision | 4 |
| Withdrew: Withdrawal by subject | 2 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence that, at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as non-serious adverse events. Number of participants with SAEs and common (greater than equal to \[\>=\] 3 percent \[%\]) non-SAEs were reported.
| Participants | Mepolizumab 100 mg SC |
|---|---|
| SAEs | 3 |
| Non-SAEs | 9 |
Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Exacerbations were treated per the investigator's clinical practice protocol with the use of oral or parenteral corticosteroids. Clinically significant exacerbations were recorded in the electronic case report form (eCRF) by the Investigator or designee were verified using data from the electronic Diary. Number of participants with clinically significant exacerbations were reported.
| Participants | Mepolizumab 100 mg SC |
|---|---|
| Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits]) | 8 |
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Number of participants with exacerbations requiring hospitalization or ED visits were reported.
| Participants | Mepolizumab 100 mg SC |
|---|---|
| Number of Participants With Exacerbations Requiring Hospitalization or ED Visits | 2 |
Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization. Number of participants with exacerbations requiring hospitalization were reported.
| Participants | Mepolizumab 100 mg SC |
|---|---|
| Number of Participants With Exacerbations Requiring Hospitalization | 2 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
| Liters | Mepolizumab 100 mg SC |
|---|---|
| Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | 0.081 ± 0.0667 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in post-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.
| Liters | Mepolizumab 100 mg SC |
|---|---|
| Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24 | 0.055 ± 0.0555 |
The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. The five questions (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms. The response options for all these questions consists of a zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-5 score is calculated as the mean of these 5 item responses and ranges from scores 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline was calculated as the value at Week 24 minus the Baseline value.
| Scores on a scale | Mepolizumab 100 mg SC |
|---|---|
| Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 | -0.69 ± 0.121 |
PEF was defined as the maximum speed of expiration of a participant, measured with electronic peak flow meter. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Liters per minute (L/min) | Mepolizumab 100 mg SC |
|---|---|
| Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24 | 13.67 ± 5.330 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were adverse events associated with the identified and potential risks of mepolizumab. AESIs were systemic/ local site reactions, all infections (Infections from Infections and infestations System Organ Class \[SOC\]), opportunistic infections, neoplasm, malignancies, cardiac disorders and serious cardiac, vascular and thromboembolic (CVT) events.
| Participants | Mepolizumab 100 mg SC |
|---|---|
| Systemic/local site reactions | 3 |
| All infections | 5 |
| Opportunistic infections | 0 |
| Neoplasm | 0 |
| Malignancies | 0 |
| Cardiac disorders | 0 |
| Serious cardiac, vascular and thromboembolic (CVT) events | 0 |
Collected over All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (non-SAEs) were collected up to Week 24. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mepolizumab 100 mg SC | 1/100 (1%) | 3/100 (3%) | 9/100 (9%) |
| Event | Mepolizumab 100 mg SC |
|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/100 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/100 |
| Event | Mepolizumab 100 mg SC |
|---|---|
| PyrexiaGeneral disorders | 5/100 |
| HeadacheNervous system disorders | 3/100 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/100 |
| Age, Continuous(Years) | Mepolizumab 100 mg SC |
|---|---|
| Mean | 44.8 ± 12.04 |
| Sex: Female, Male(Participants) | Mepolizumab 100 mg SC |
|---|---|
| Female | 51 |
| Male | 49 |
| Race/Ethnicity, Customized(Participants) | Mepolizumab 100 mg SC |
|---|---|
| Asian - Central/South Asian Heritage | 100 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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