Search results - Portal of Medical Data Models (MDM-Portal)

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

- 11/17/18 - 1 form, 9 itemgroups, 81 items, 1 language

Itemgroups: 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 Stage III Non-small Cell Lung Cancer NCT02076282

- 7/10/19 - 1 form, 2 itemgroups, 15 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

MRI Optimization Study in Stage III NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02076282

Eligibility Recurrent Non-small Cell Lung Cancer NCT02059889

- 6/27/19 - 1 form, 2 itemgroups, 10 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02059889

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

- 10/27/18 - 1 form, 20 itemgroups, 128 items, 1 language

Itemgroups: 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 Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD 102970 - Common CRF

- 4/30/20 - 1 form, 13 itemgroups, 178 items, 1 language

Itemgroups: Administrative documentation, Non-serious Adverse Event, Serious Adverse Event, COPD exacerbation, Concomitant Agent, Fracture, Experimental drug, Compliance behavior, Experimental drug, Compliance behavior, Investigational Medicinal Product Documentation, Device Malfunction, Plain chest X-ray, Pneumonia, Evaluation, Imaging of liver, Biopsy of liver

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970 - Rescreening

- 2/24/19 - 1 form, 15 itemgroups, 92 items, 1 language

Itemgroups: Administrative documentation, Oropharyngeal candidiasis, Medical Examination, Disease Length, Date of visit, Assessment Date, Trial Screen Failure, Eligibility Determination, Inclusion, Exclusion Criteria, COPD exacerbation, Medical History, Investigator Signature, Laboratory Procedures, Disease, Plain chest X-ray, History of tobacco use, Vital Signs

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD 102970 - LOGS

- 5/28/19 - 1 form, 16 itemgroups, 166 items, 1 language

Itemgroups: Administrative documentation, Non-serious Adverse Event, Serious Adverse Event, COPD exacerbation, Concomitant Agent, Date of visit, Assessment Date, Fracture, Pharmacogenetics, Informed Consent; Sampling, Experimental drug, Compliance behavior, Experimental drug, Compliance behavior, Investigational Medicinal Product Documentation, Device Malfunction, Plain chest X-ray, Pneumonia, Evaluation, Event Log, Status, Serious Adverse Event, Status, Study Subject Participation Status

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

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

- 8/8/17 - 1 form, 17 itemgroups, 47 items, 1 language

Itemgroups: 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

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970 - Screening

- 2/20/19 - 1 form, 20 itemgroups, 100 items, 1 language

Itemgroups: Administrative documentation, Oropharyngeal candidiasis, Medical Examination, Demography, Disease Length, Date of visit, Assessment Date, Trial Screen Failure, Eligibility Determination, Inclusion, Exclusion Criteria, COPD exacerbation, Medical History, Investigator Signature, Laboratory Procedures, Disease, Plain chest X-ray, Study Subject Participation Status, Screening Procedure, Repeat, Screening procedure, Status, Clinical Trial Subject Unique Identifier, History of tobacco use, Vital Signs

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

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