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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

- 2019-05-08 - 1 Formulär, 13 Item-grupper, 104 Dataelement, 1 Språk
Item-grupper: Date of Visit, Liver Event Assessment, Liver Events, Investigational Product (Liver) - during treatment period, Investigational Product (Liver) - after treatment period , Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Liver Imaging

- 2018-12-04 - 1 Formulär, 12 Item-grupper, 63 Dataelement, 1 Språk
Item-grupper: Administrative data, Liver imaging, Method of imaging test, Image quality, Liver size, Liver texture, Ddiffuse and/or geographic fatty infiltrate of liver, Ascites, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the liver imaging form. It has to be filled in during study, if a liver imaging was taken from subject.

GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463 - Chest X-Ray

- 2018-04-05 - 1 Formulär, 1 Item-grupp, 17 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Chest X-Ray

Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) GSK102871 - Chest X-Ray

- 2018-03-21 - 1 Formulär, 1 Item-grupp, 17 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Chest X-Ray

transition dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-16 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: administrative data, transition dyspnoea index
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 11 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: administrative data, baseline dyspnoea index, job, housework, shopping, leisure activities, gardening, social participation, washing, dressing, at rest, other aspect, baseline dyspnoea index score, date
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 17 Item-grupper, 47 Dataelement, 1 Språk
Item-grupper: administrative data, demography, medical condition, tobacco use, COPD, oropharyngeal candidasis examination, Chest x-ray, modified medical research council dyspnoea scale, 12-lead ECG, pulmonary function testing, pulmonary funtion testing: FEV1, pulmonary function testing: FVC, pulmonary function testing: FEV1 /FVC ratio, fat free mass, laboratory blood, St. George's respiratory questionnaire, baseline dyspnoea index
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

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