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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Status of Treatment Blind

- 2020-07-28 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk

Item-grupper: Administrative, Status of Treatment Blind

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)

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Follow-Up

- 2018-12-14 - 1 Formulär, 7 Item-grupper, 41 Dataelement, 1 Språk

Item-grupper: Physical Examination, Vital Signs, 12 lead ECG, 12 lead ECG, Abnormality, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

investigational product and blinded study salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 7 Item-grupper, 14 Dataelement, 1 Språk

Item-grupper: administrative data, INVESTIGATIONAL PRODUCT, investigational product compliance, investigational product compliance, investigational product compliance, investigational product compliance, treatment status of blinded clinical study

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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

- 2020-12-05 - 1 Formulär, 9 Item-grupper, 36 Dataelement, 1 Språk

Item-grupper: Date of visit/assessment, ECG, Vital Signs - Follow-up 1, Vital Signs - Follow-up 2, Vital Signs - Follow-up 3, Pulmonary Function Tests, Pregnancy Information, Status of Treatment Blind, Study Conclusion

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

- 2023-12-01 - 4 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk

Item-grupp: IG.elig

Principal Investigator: Vasan Ramachandran, Department of Medicine, Boston University School of Medicine, Boston, MA, USA MeSH: Cardiovascular Diseases,Atherosclerosis,Atrial Fibrillation,Death, Sudden, Cardiac,Diabetes Mellitus, Type 2,Heart Failure,Blood Pressure,Hypertension,Body Mass Index,Adiposity,Lipids,Pulmonary Disease, Chronic Obstructive,Renal Insufficiency, Chronic,Stroke,Osteoporosis,Risk Factors,Biological Markers,Biomarkers, Pharmacological https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000974 The Framingham Heart Study (FHS) is a prospective cohort study of 3 generations of subjects who have been followed up to 65 years to evaluate risk factors for cardiovascular disease. Its large sample of ~15,000 men and women who have been extensively phenotyped with repeated examinations make it ideal for the study of genetic associations with cardiovascular disease risk factors and outcomes. DNA samples have been collected and immortalized since the mid-1990s and are available on ~8000 study participants in 1037 families. These samples have been used for collection of GWAS array data and exome chip data in nearly all with DNA samples, and for targeted sequencing, deep exome sequencing and light coverage whole genome sequencing in limited numbers. Additionally, mRNA and miRNA expression data, DNA methylation data, metabolomics and other 'omics data are available on a sizable portion of study participants. This project will focus on deep whole genome sequencing (mean 30X coverage) in ~4100 subjects and imputed to all with GWAS array data to more fully understand the genetic contributions to cardiovascular, lung, blood and sleep disorders. Comprehensive phenotypic and pedigree data for study participants are available through dbGaP phs000007.

pht004909.v3.p3

1 Item-grupp 2 Dataelement

pht004910.v4.p3

1 Item-grupp 2 Dataelement

pht004911.v3.p3

1 Item-grupp 9 Dataelement

study conclusion events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 6 Item-grupper, 11 Dataelement, 1 Språk

Item-grupper: administrative data, study conclusion, medical device, pregnancy, investigator's comment, investigator's signature

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

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Alcohol test, drug screen

- 2018-11-30 - 1 Formulär, 4 Item-grupper, 10 Dataelement, 1 Språk

Item-grupper: Administrative data, ALCOHOL INTAKE, ALCOHOL BREATH TEST, DRUG 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: 1)alcohol intake form. It has to be filled in for screening. 2)alcohol breath test form. It has to be filled in for screening and study visit. 3) drug screen form. It has to be filled in for screening and study visit.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Serious Adverse Event (SAE)

- 2019-01-17 - 1 Formulär, 15 Item-grupper, 64 Dataelement, 1 Språk

Item-grupper: Administrative data, Serious Adverse Events, Demography, Serious adverse events, Possible Causes of SAE other than lnvestigational Product(s), Seriousness of SAE, Relevant Medical Conditions, Other relevant risk factors, Details of lnvestigational Product(s), Relevant Concomitant Medications, Narrative / Comments, Details of relevant Assessments, Reporting lnvestigator, Additional or follow-up information, Reporting lnvestigator

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about serious adverse events and should be completed only in case of occurrence of serious adverse events.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Pharmacokinetic Blood and Urine Sampling

- 2019-01-17 - 1 Formulär, 3 Item-grupper, 18 Dataelement, 1 Språk

Item-grupper: Administrative data, Pharmacokinetic blood sampling, Pharmacokinetic urine sampling

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive This form contains information about pharmacokinetic blood and urine sampling. It has to be filled in in Session 2.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Pharmacogenetic Research

- 2019-01-17 - 1 Formulär, 5 Item-grupper, 9 Dataelement, 1 Språk

Item-grupper: Administrative data, Consent for Pharmacogenetic Research, Blood Sample Collection, Withdrawal of Consent, Blood Sample Destruction

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive.

withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 13 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: administrative data, current tobacco use, oropharyngeal candidasis examination, fat free mass, laboratory blood, vital signs, pulmonary function testing, pulmonary funtion testing: FEV1, pulmonary function testing: FVC, pulmonary function testing: FEV1 /FVC ratio, St. George's respiratory questionnaire, EQ-5D, subject and physician global impression

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

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome

- 2020-11-11 - 1 Formulär, 4 Item-grupper, 41 Dataelement, 1 Språk

Item-grupper: Administrative Data, Chest X-ray, Cultures and clinical findings, Treatment and Outcome

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.

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