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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - History of Tobacco Use

- 28/11/18 - 1 modulo, 1 ItemGroup, 3 elementi, 1 linguaggio

ItemGroup: History of tobacco use

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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

- 07/01/21 - 1 modulo, 7 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative, Alcohol Intake, Alcohol Breath Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Urine Cotinine Test, History of Tobacco Use

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

- 26/06/20 - 1 modulo, 6 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use, Serology

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Tobacco use, HIV screen

- 04/12/18 - 1 modulo, 3 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative data, HISTORY OF TOBACCO USE, SEROLOGY - HIV SCREEN

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 history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/16 - 1 modulo, 11 itemgroups, 42 elementi, 1 linguaggio

Itemgroups: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed Applicable, Study Drug Dispensed

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Unscheduled Visit

Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/16 - 1 modulo, 8 itemgroups, 27 elementi, 1 linguaggio

Itemgroups: Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Open-label Tarceva Dispensed

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Open-label Baseline Assessments

Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/16 - 1 modulo, 16 itemgroups, 104 elementi, 1 linguaggio

Itemgroups: Medical and Surgical History, Significant Medical and Surgical History, NSCLC Diagnosis, NSCLC-related Surgery, Tobacco/Nicotine History at Randomization, Prior Adjuvant Chemotherapy, Prior Adjuvant Chemotherapy for NSCLC, Optional Research Blood Sample, Radiology, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Study Drug Dispensed, Investigator's Signature

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Baseline Assessments

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/16 - 1 modulo, 10 itemgroups, 40 elementi, 1 linguaggio

Itemgroups: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: On-Treatment Assessments

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888 - Alcohol intake; urine test for drugs, cotinine and alcohol; history of tobacco use

- 04/02/19 - 1 modulo, 4 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative data, Alcohol intake, Urine test for drugs, cotinine and alcohol, History of tobacco use

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains Alcohol intake; urine test for drugs, cotinine and alcohol; history of tobacco use. It has to be filled in for screening.

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