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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
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  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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661 Search results.

Screening - GSK Milveterol COPD 100527

- 6/18/17 - 1 form, 9 itemgroups, 132 items, 1 language
Itemgroups: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Laboratory Result Data; Urinalysis

- 8/12/20 - 1 form, 10 itemgroups, 20 items, 1 language
Itemgroups: Administrative, Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Haematology Test (Treatment Period 1, 2, 3, 4, 5), Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5), Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5), Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5) , Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5) , Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5) , Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

- 8/9/20 - 1 form, 14 itemgroups, 79 items, 1 language
Itemgroups: Administrative, Randomisation Number (Treatment Period 1), Investigational Product, Treatment Confirmation, Pharmacokinetics - Blood (Treatment Period 1), Pharmacokinetics - Blood (Treatment Period 2) , Pharmacokinetics - Blood (Treatment Period 3) , Pharmacokinetics - Blood (Treatment Period 4) , Pharmacokinetics - Blood (Treatment Period 5) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1), Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3), Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4) , Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 8/3/20 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Non-serious Adverse Events (AE); Serious Adverse Events (SAE)

- 7/29/20 - 1 form, 16 itemgroups, 59 items, 1 language
Itemgroups: Administrative, Non-serious Adverse Events (AE), Non-serious Adverse Events (AE) , Serious Adverse Event (SAE), Serious Adverse Event (SAE) - Section 1, Serious Adverse Event (SAE) - Section 2 Seriousness, Serious Adverse Event (SAE) - Section 3 Demography Data, Serious Adverse Event (SAE) - Section 4, Serious Adverse Event (SAE) - Section 5 , Serious Adverse Event (SAE) - Section 6 Relevant Medical Conditions, Serious Adverse Event (SAE) - Section 7 Other relevant risk factors, Serious Adverse Event (SAE) - Section 8 Concomitant medications , Serious Adverse Event (SAE) - Section 9 Details of investigational product(s), Serious Adverse Event (SAE) - Section 10, Serious Adverse Event (SAE) - Section 11 Narrative remarks, Investigator's signature
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Status of Treatment Blind

- 7/28/20 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: 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)

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - PGx-Pharmacogenetic Research; Concomitant Medications

- 7/28/20 - 1 form, 4 itemgroups, 23 items, 1 language
Itemgroups: Administrative, PGx-Pharmacogenetic Research, Concomitant Medications, Concomitant Medications
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - 12-Lead ECG Abnormalities; Holter ECG Abnormalities; ECG Abnormalities (Lead II Monitoring)

- 7/27/20 - 1 form, 7 itemgroups, 43 items, 1 language
Itemgroups: Administrative, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Holter ECG Abnormalities, 12-Lead ECG Abnormalities , ECG Abnormalities (Lead II Monitoring), ECG Abnormalities (Lead II Monitoring)
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - 12-Lead ECG Abnormalities; Holter ECG Abnormalities; ECG Abnormalities (Lead II Monitoring)

- 7/27/20 - 1 form, 7 itemgroups, 43 items, 1 language
Itemgroups: Administrative, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Holter ECG Abnormalities, 12-Lead ECG Abnormalities , ECG Abnormalities (Lead II Monitoring), ECG Abnormalities (Lead II Monitoring)
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pulmonary Function Tests; Pulmonary Function Tests - Investigator Calculation; Plethysmography Pre-Ipratropium Bromide; Ipratropium Bromide Administration; Plethysmography Post-Ipratropium Bromide; Plethysmography Post-Ipratropium Bromide - Investigator Calculation (Screening)

- 7/25/20 - 1 form, 7 itemgroups, 32 items, 1 language
Itemgroups: Administrative, Pulmonary Function Tests, Pulmonary Function Tests - Investigator Calculation, Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide), Ipratropium Bromide Administration, Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide), Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Investigator Calculation
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pulmonary Function Tests; Plethysmography (Treatment Period 1-5)

- 7/25/20 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative, Pulmonary Function Tests, Pulmonary Function Tests (Plethysmography)
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, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - 24 Hrs Holter ECG; 12-Lead ECG

- 7/24/20 - 1 form, 8 itemgroups, 51 items, 1 language
Itemgroups: Administrative, 24 Hrs Holter ECG (Screening), 24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5), 24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5), 12-Lead ECG (Screening), 12-Lead ECG (Mean Calculation) (Screening), 12-Lead ECG (Treatment Period 1, 2, 3, 4, 5) , 12-Lead ECG (Follow-Up)
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)