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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Screening - GSK Milveterol COPD 100527

- 9/20/21 - 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

Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 23 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00525512

Tele-yoga Program in COPD and Heart Failure (Tele-Yoga) NCT02078739 - Eligibility Tele-Yoga NCT02078739

- 11/18/21 - 1 form, 2 itemgroups, 16 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
A controlled, non-randomised trial was conducted of an 8-week Tele-Yoga intervention versus an educationalcontrol (information leaflets mailed to participants with one phone call a week). Biweekly one-hour Tele-Yoga classeswere implemented via multipoint videoconferencing that connected participants to live classes via an Internet connectionto their televisions. Semi-structured qualitative interviews were conducted with participants post study exit to explorereasons for and experiences of participating, including views of study outcome measures and physiologicaltests. Transcribed interviews were analysed using thematic content analysis.

Eligibility Chronic Obstructive Pulmonary Disease NCT00981851

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Interaction in Chronic Obstructive Pulmonary Disease Experiment; ODM derived from: https://clinicaltrials.gov/show/NCT00981851

Main CRF (Treatment Period 4, Day 7) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 13 itemgroups, 100 items, 1 language
Itemgroups: Hematology Day 7 Pre-Dose,Clinical chemistry Day 7 Pre-Dose,Urinalysis Day 7 Pre-Dose,Investigational Product Day 7,Vital Signs Day 7,12-Lead Electrocardiogram Day 7,FEV1 Day 7,Pharmacokinetic sampling Day 7,Potassium and Glucose Day 7,Pharmacokinetic Urine lnterval Collection Data Day 7,Hematology Day 7 Post-Dose,Clinical chemistry Day 7 Post-Dose,Urinalysis Day 7 Post-Dose
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

Follow-up - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 5 itemgroups, 42 items, 1 language
Itemgroups: Vital Signs Follow-up,12-Lead Electrocardiogram Follow-up,Hematology Follow-up,Clinical chemistry Follow-up,Urinalysis Follow-up
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

Main CRF (Treatment Period 4, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1,Investigational Product Day 2,Hematology Day 1 Pre-Dose,Clinical chemistry Day 1 Pre-Dose,Urinalysis Day 1 Pre-Dose,Vital Signs Day 1,Vital Signs Day 2,12-Lead Electrocardiogram Day 1,12-Lead Electrocardiogram Day 2,FEV1 Day 1,Pharmacokinetic sampling Day 1,Potassium and Glucose Day 1,Pharmacokinetic Urine lnterval Collection Data Day 1,Hematology Day 1 Post-Dose,Clinical chemistry Day 1 Post-Dose,Urinalysis Day 1 Post-Dose
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

Main CRF (Treatment Period 3, Day 7) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 13 itemgroups, 100 items, 1 language
Itemgroups: Hematology Day 7 Pre-Dose,Clinical chemistry Day 7 Pre-Dose,Urinalysis Day 7 Pre-Dose,Investigational Product Day 7,Vital Signs Day 7,12-Lead Electrocardiogram Day 7,FEV1 Day 7,Pharmacokinetic sampling Day 7,Potassium and Glucose Day 7,Pharmacokinetic Urine lnterval Collection Data Day 7,Hematology Day 7 Post-Dose,Clinical chemistry Day 7 Post-Dose,Urinalysis Day 7 Post-Dose
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

Main CRF (Treatment Period 3, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1,Investigational Product Day 2,Hematology Day 1 Pre-Dose,Clinical chemistry Day 1 Pre-Dose,Urinalysis Day 1 Pre-Dose,Vital Signs Day 1,Vital Signs Day 2,12-Lead Electrocardiogram Day 1,12-Lead Electrocardiogram Day 2,FEV1 Day 1,Pharmacokinetic sampling Day 1,Potassium and Glucose Day 1,Pharmacokinetic Urine lnterval Collection Data Day 1,Hematology Day 1 Post-Dose,Clinical chemistry Day 1 Post-Dose,Urinalysis Day 1 Post-Dose
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

Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 6 itemgroups, 46 items, 1 language
Itemgroups: Vital Signs Day 3-6,12-Lead Electrocardiogram Day 3-6,FEV1 Day 3-6,Pharmacokinetic sampling Day 5-6,Potassium Day 5-6,Investigational Product Day 3-6
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

Main CRF (Treatment Period 4, Day 3-6) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 6 itemgroups, 46 items, 1 language
Itemgroups: Vital Signs Day 3-6,12-Lead Electrocardiogram Day 3-6,FEV1 Day 3-6,Pharmacokinetic sampling Day 5-6,Potassium Day 5-6,Investigational Product Day 3-6
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

Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1,Investigational Product Day 2,Hematology Day 1 Pre-Dose,Clinical chemistry Day 1 Pre-Dose,Urinalysis Day 1 Pre-Dose,Vital Signs Day 1,Vital Signs Day 2,12-Lead Electrocardiogram Day 1,12-Lead Electrocardiogram Day 2,FEV1 Day 1,Pharmacokinetic sampling Day 1,Potassium and Glucose Day 1,Pharmacokinetic Urine lnterval Collection Data Day 1,Hematology Day 1 Post-Dose,Clinical chemistry Day 1 Post-Dose,Urinalysis Day 1 Post-Dose
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

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