Long Term Special Drug Use Investigation of Mepolizumab

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03028480
• Other study ID #: 204524
• Status: Active, not recruiting
• Start date: January 11, 2017
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects whose data enetered on Electronic data capture (EDC) system	This includes the number of enrolled subjects whose data is entered in the EDC system.	Up to 3 years
Primary	Incidence of adverse drug reaction	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
Primary	Number of subjects showing Response to the treatment	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
Primary	Number of subjects excluded from analysis due to exacerbation of asthma	Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids	Up to Week 52
Primary	Number of subjects having adverse drug reactions (ADR)	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
Primary	Number of subjects require priority investigation matter	Priority investigation matters include, Hypersensitivity reaction including anaphylaxis, infections, malignant tumour	Up to 3 years
Secondary	Response rate assessed by global assessment of effectiveness	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
Secondary	Frequency of exacerbation of asthma	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
Secondary	Total score of Asthma Control Test (ACT)	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
Secondary	Number of subjects having normal Peak Expiratory Flow (PEF) score	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