Long Term Special Drug Use Investigation of Mepolizumab

Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)

This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: NUCALA Injection

• Study Type: Observational
• Enrollment (Actual): 1061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Description

Inclusion Criteria:

• Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Bronchial asthma; Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled	Drug: NUCALA Injection; Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System	The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.	Up to 14 days from the initiation of NUCALA treatment (Day 1)
Percentage of Participants With Adverse Drug Reaction (ADR)	ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment*100. Percentage values are rounded-off.	Up to 3 years
Number of Participants Showing Response to the Treatment	The number of participants who showed response to the bronchial asthma treatment has been presented.	Up to 1 year
Number of Participants Excluded From Analysis Due to Exacerbation of Asthma	The number of participants excluded from analysis due to exacerbation of asthma has been presented.	Up to 1 year
Number of Participants With Adverse Drug Reactions (ADR)	ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.	Up to 3 years
Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters	Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate Assessed by Global Assessment of Effectiveness	Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. Response rate and corresponding 95% confidence interval were reported.	Up to 1 year
Rate of Exacerbation of Asthma	Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in hospitalization, emergency room visit and usage of systemic steroids. Exacerbation rate was defined as number of asthma exacerbations divided by total person-year (52 weeks were converted to 1 year). Data for exacerbations requiring hospitalization, emergency room visit, and use of systemic corticosteroid have been presented.	52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment
Total Score of Asthma Control Test (ACT) at Indicated Time Points	The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).	Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Mean Peak Expiratory Flow (PEF) at Indicated Time Points	Peak Expiratory Flow is a person's maximum speed of expiration. PEF was measured using an electronic peak expiratory flow device (ePEF) at Baseline (Day 1), and at Weeks 12, 24, and 54 after the initiation of NUCALA treatment. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).	Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Mepolizumab; Exacerbation; NUCALA
• Other Study ID Numbers: 204524

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No