All Visit 2 assessments completed and confirm subject is not a run in failure?
Item
Were all Visit 2 assessments completed as per the protocol and confirm subject is not a run in failure?
boolean
C0545082 (UMLS CUI [1,1]) C0220825 (UMLS CUI [1,2]) C0205197 (UMLS CUI [1,3]) C2348563 (UMLS CUI [1,4]) C0681850 (UMLS CUI [2,1]) C1710476 (UMLS CUI [2,2])
Evening pre- dose FEV1 of between 40% and 90% of their predicted normal at Visit 3. (1)
CL Item
Demonstrated and reported in an eDiary, symptoms of asthma (a score of >=1 on day- time or night- time asthma symptom scores) and/ or daily albuterol/ salbutamol use on >= 4 od the last consecutive days of the run- in period. (2)
CL Item
Subjects recorded the use of run- in asthma controller medication on >= 4 of the last 7 consecutive days of the run- in period (3)
CL Item
Compliance with completion of the Daily Diary reporting defined as completion of all questions on >= 4 of the last 7 consecutive days of the run- in period. (4)
Evidence of clinically significant abnormal laboratory tests during Visit 1 which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/ her own discretion in determining the clinical significance of the abnormality. (1)
CL Item
Changes in asthma medication (excluding albuterol/ salbutamol inhalation aerosol provided at Visit 1). (2)
CL Item
Occurence of a culture- documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run- in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subjects asthma status or the subjects ability to participate the study. (3)
CL Item
Evidence of significant abnormality in the 12- lead ECG performed at Visit 2 and/ or Visit 3 (in the subsent of subjects undergoing ECGs at Visit 3). Selected specific ECG findings that are considered to be significant and will exclude the subject from study participation include, but are not limited to, the following: (4)
- Evidence of Mobitz II second degree or third degree atrioventricular (AV) block (9)
CL Item
- Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or >25% of the height of the corresponding R wave, provicing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. (10)
CL Item
Note: prior evidence (i.e., ECG obtained at last 12 months prior) of pathological Q waves that are unchanged are not exclusionary. (11)
CL Item
- Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. (12)
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450msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Subjects with right bundle branch block should be excluded if the QTc(F) is >= 480msec. (- QTc(F) >)
CL Item
450msec, or >=480 in subjects with right bundle branch block, should be confirmed by three readings at least 5 minutes apart. (Note: QTc(F) >)
CL Item
- ST- T wave abnormalities (excluding non-specific ST- T wave abnormalities) (15)
CL Item
- Bifascicular block (i.e. Complete left bundle branch block [CLBBB] or complete right bundle branch block with concomitant left fascicular block) (16)
Evidence of a severe exacerbation, defined as deterioration of asthma requiring the use of systemic corticoidsteroids (tablets, suspension, or injection) for at least 3 days or an in- patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids between Visits 1 and 3. (5)
CL Item
Clinical visual evidence of oral candidiasis at the Randomization Visit (Visit3). (6)
CL Item
Subject is unable to use the inhaler correctly after 3 seperate demonstrations at Randomisation Visit (Visist 3). (7)
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)