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Randomisation Criteria List

1 Formulários  
Randomisation criteria question
Descrição

Randomisation criteria question

Did the subject meet all of the Randomisation criteria?
Descrição

Did the subject meet all of the Randomisation criteria?

Tipo de dados

boolean

If NO, please select all boxes corresponding to violations of any randomisation criteria
Descrição

If NO, please select all boxes corresponding to violations of any randomisation criteria

Inclusion
Descrição

Inclusion

1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
Descrição

1. Evening pre-dose of FEV1 50% to 90% of the predicted normal

Tipo de dados

boolean

2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
Descrição

2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

1. 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 discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
Descrição

1. 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 discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.

Tipo de dados

boolean

2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
Descrição

2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2

Tipo de dados

boolean

3. Occurrence 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 in the study
Descrição

3. Occurrence 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 in the study

Tipo de dados

boolean

4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
Descrição

If a subject experiences a severe asthma exacerbation during run-in , they may extend the run-in period to recover from the symptoms and wash-out any prohibited medications.

Tipo de dados

boolean

5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. 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:
Descrição

5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. 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:

Tipo de dados

text

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Randomisation Criteria List

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Randomisation criteria question
Did the subject meet all of the Randomisation criteria?
Item
Did the subject meet all of the Randomisation criteria?
boolean
Item Group
If NO, please select all boxes corresponding to violations of any randomisation criteria
Item Group
Inclusion
1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
Item
1. Evening pre-dose of FEV1 50% to 90% of the predicted normal
boolean
2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
Item
2. A documented use of albuterol/salbutamol and/or asthma symptoms on at least 3 of the last 7 consecutive days of the run-in period
boolean
Item Group
Exclusion Criteria
1. 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 discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
Item
1. 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 discretion in determining the clinical significance of the abnormality. When in doubt, GSK, or designee should be notified so that a joint decision can be made.
boolean
2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
Item
2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1) occuring between Visits 1 and 2
boolean
3. Occurrence 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 in the study
Item
3. Occurrence 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 in the study
boolean
4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
Item
4. Asthma exacerbation requiring in-patient hospitalisation or emergency department visit between Visits 1 and 2
boolean
Item
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. 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:
text
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. 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:
Code List
5. Evidence of significant abnormality in the 12-lead ECG performed at Visit 1, as judged by the investigator. 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:
CL Item
sinus bradycardia < 45 bpm (1)
CL Item
sinus tachycardia >=110 bpm (2)
CL Item
multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) (3)
CL Item
PR Interval >240 msec (4)
CL Item
Evidence of Mobitz II second or thrid degree atrioventricular (AV) block (5)
CL Item
Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm/mV setting)] or 25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5 mm with 10mm/mV setting] appearing in at least two contiguous leads) (6)
CL Item
Evidence of ventricular ectopic couplets, bigemy, trigemy or multifocal premature ventricular complexes (7)
CL Item
QTcF >=450msec or uncorrected QT> 600msecor an ECG that is not suitable for QT measurements (e.g., poor defined termination of the T wave) (8)
CL Item
ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities) (9)
CL Item
Right or left complete bundle branch block (10)
CL Item
Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-WHite syndrome) (11)
CL Item
Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) (12)
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