- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028480
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
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
Keywords
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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