Long Term Special Drug Use Investigation of Mepolizumab

October 27, 2021 updated by: GlaxoSmithKline

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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 subjects whose data enetered on Electronic data capture (EDC) system
Time Frame: Up to 3 years
This includes the number of enrolled subjects whose data is entered in the EDC system.
Up to 3 years
Incidence of adverse drug reaction
Time Frame: Up to 3 years
It will be calculated as the number of subjects having adverse drug reaction by total number of subjects on NUCALA treatment
Up to 3 years
Number of subjects showing Response to the treatment
Time Frame: Up to Week 52
Response rate will be calculated as number of subjects showing response to the NUCALA treatment by total number of subjects on treatment
Up to Week 52
Number of subjects excluded from analysis due to exacerbation of asthma
Time Frame: Up to Week 52
Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids
Up to Week 52
Number of subjects having adverse drug reactions (ADR)
Time Frame: Up to 3 years
ADR is defined as , a response to a drug which is noxious and unintended, and which occurs 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
Number of subjects require priority investigation matter
Time Frame: Up to 3 years
Priority investigation matters include, Hypersensitivity reaction including anaphylaxis, infections, malignant tumour
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate assessed by global assessment of effectiveness
Time Frame: Up to Week 52
The response rate is the proportion of subjects assessed as "effective" based on the course of subjective symptoms, and course of clinical symptoms
Up to Week 52
Frequency of exacerbation of asthma
Time Frame: Up to Week 52
Frequency will be analyzed 52 weeks prior to the initiation of NUCALA treatment. Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids
Up to Week 52
Total score of Asthma Control Test (ACT)
Time Frame: Up to Week 52
Information on ACT will be recorded by subjects before the initiation of the therapy and at Week 12, Week 24 and Week 52 after administration.
Up to Week 52
Number of subjects having normal Peak Expiratory Flow (PEF) score
Time Frame: Up to Week 54
PEF is the Respiratory Function Test. It will be measured (at morning or evening) at the nearest time point of 1 week before and after the initiation of NUCALA treatment
Up to Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 11, 2017

Primary Completion (ANTICIPATED)

January 31, 2024

Study Completion (ANTICIPATED)

January 31, 2024

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 204524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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