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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - X Ray Pneumonia Confirmation (X-ray)

- 08.01.19 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, X Ray Pneumonia Confirmation (X-ray)
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, 4 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 the X Ray Pneumonia Confirmation (X-ray) form. It has to be filled in for each x-ray for pneumonia confirmation performed during trial, if necessary.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Chest X-Ray Data

- 04.12.18 - 1 Formular, 1 Itemgruppe, 2 Datenelemente, 1 Sprache
Itemgruppe: Chest X-Ray
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

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Log Status Form

- 30.11.18 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: Log Status
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

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Concomitant Medications, Asthma Exacerbations, IP Device Malfunction, Chest X-Ray, Pharmacogenetic Research Consent/ Sample Collection, Investigational Product Compliance and Unsceduled Asthma related Healthcare Resource Utilisation - Subject Logs

- 17.11.18 - 1 Formular, 9 Itemgruppen, 81 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Medication, Asthma Exacerbations, Contact Method/ Treatment site for ExacerbationsMethod, Exacerbation Medications, IP Device Malfunction, Chest X-Ray, Pharmacogenetic (PGx) Research Consent/ Sample Collection, Investigational Product Compliance, Unscheduled Asthma related Healthcare Resource Utilisation
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Eligibility Asthma NCT02351141

- 14.04.16 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Structure and Function MRI of Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02351141

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Logs/ Repeats, Non- Serious Adverse Event, Serious Adverse Event, Concomitant Medication, Electronically Transferred Lab Data, Vital Signs, ECG, Repeat Pharmacodynamics - Cortisol, Glucose, Potassium, FF/GWG642444M, Defective Inhaler, X Ray Pneumonia Confirmation

- 27.10.18 - 1 Formular, 20 Itemgruppen, 128 Datenelemente, 1 Sprache
Itemgruppen: Date of Visit/ Assessment, Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions, Non- serious Adverse Event, Serious Adverse Event, Relevant medical conditions/ risk factors, Relevant Concomitant/ Treatment Medications, Relevant Diagnostic Results, Investigational Product, General Narrative Comments, Concomitant Medication, Electronically transferred lab data, Vital signs , 12- Lead ECG, ECG Abnormalities, Pharmacodynamics - Cortisol , Pharmacodynamics Results - Glucose, Pharmacodynamics Results - Potassium, Pharmacokinetics Blood - FF/GW642444M , Defective Inhaler, X Ray Pneumonia Confirmation
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Liver biopsy

- 06.01.19 - 1 Formular, 14 Itemgruppen, 158 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver biopsy, Final diagnosis, Liver Architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal veins, Liver Infections, Parasites or Ova, Histologic Staining or Additional Studies Obtained
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, 4 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 the liver biopsy form. It has to be filled in if a liver biopsy is taken during study.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Liver Biopsy Data

- 07.12.18 - 1 Formular, 14 Itemgruppen, 108 Datenelemente, 1 Sprache
Itemgruppen: Date of liver biopsy, Biopsy size, Final diagnosis of biopsy, Liver architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal tract Inflamation, Bile ducts, Portal veins, Liver Infections, Parasites or Ova, Histologic Staining or Additional Studies Obtained
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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