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32507
Beschreibung
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
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- 05.11.18 05.11.18 -
- 06.12.18 06.12.18 -
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GSK group of companies
Hochgeladen am
5. November 2018
DOI
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Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Randomisation Criteria List
- StudyEvent: ODM
Ähnliche Modelle
Randomisation Criteria List
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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
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
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
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)