A safety study for subjects with severe asthma who participated in MEA115575 or MEA115588

• Conditions: Subjects with Severe Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001644-21-NL
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
2. MEA115588 or MEA11575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA11575.
3. Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., ICS or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
4. Male or eligible female subjects:
5. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (Appendix 2) for the duration of the trial and for 4 months after the last study drug administration.
6. A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 620
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
2. Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
3. Malignancy: A current malignancy or malignancy that developed during
MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]
4. Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
5. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
6. ECG: Baseline ECG which has a clinically significant abnormality or which shows QTcF =450msec or QTcF =480msec for subjects with Bundle Branch Block.
7. Smoking status: Current smokers

Subjects should also be excluded if any of the following are met:
1. Liver Function: Liver Function Tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 :
ALT =2 x ULN (upper limit of normal)
AST =2 x ULN
Alk Phos =2 x ULN
Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%

2. Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1

3. ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified