ID
33704
Description
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains logs and repeat. It has to be filled in for the end of study.
Lien
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Mots-clés
Versions (3)
- 20/12/2018 20/12/2018 -
- 20/12/2018 20/12/2018 -
- 27/09/2021 27/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 décembre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Logs and repeat
- StudyEvent: ODM
Description
Adverse event/Concomitant medication/unscheduled assessment check questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Description
Take of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Non-serious adverse events
Type de données
text
Alias
- UMLS CUI [1]
- C1518404
Description
Investigational Product Device Malfunctions
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0086138
Description
Serious adverse events
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
Take of unscheduled haematology or clinical chemistry samples
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [2,1]
- C3854240
- UMLS CUI [2,2]
- C0018941
Description
Take of unscheduled urinalysis samples
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0042014
Description
Unscheduled ECGs
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0013798
Description
Abnormal, clinically significant ECG
Type de données
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Description
Unscheduled vital signs
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0518766
Description
Take of chest x-rays
Type de données
text
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0032285
- UMLS CUI [1,3]
- C0750491
Description
Unscheduled FEV1
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0748133
Description
Take of unscheduled PK blood
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [2,1]
- C3854240
- UMLS CUI [2,2]
- C0178913
Description
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
lf Yes to Liver events, go to the LE DETAILS visit and complete the Liver event forms
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Similar models
Logs and repeat
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C0086138 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C0042014 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C0032285 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0748133 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
C0877248 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])