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

- 20.09.21 - 1 Formular, 16 Itemgruppen, 123 Datenelemente, 1 Sprache
Itemgruppen: 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 1-2) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 16 Itemgruppen, 123 Datenelemente, 1 Sprache
Itemgruppen: 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 4, Day 1-2) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 16 Itemgruppen, 123 Datenelemente, 1 Sprache
Itemgruppen: 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 4, Day 7) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 13 Itemgruppen, 100 Datenelemente, 1 Sprache
Itemgruppen: 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 7) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 13 Itemgruppen, 100 Datenelemente, 1 Sprache
Itemgruppen: 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 4, Day 3-6) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 6 Itemgruppen, 46 Datenelemente, 1 Sprache
Itemgruppen: 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 3, Day 3-6) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 6 Itemgruppen, 46 Datenelemente, 1 Sprache
Itemgruppen: 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 2, Day 7) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 13 Itemgruppen, 100 Datenelemente, 1 Sprache
Itemgruppen: 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 1, Day 1-2) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 16 Itemgruppen, 123 Datenelemente, 1 Sprache
Itemgruppen: 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 1, Day 7) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 13 Itemgruppen, 100 Datenelemente, 1 Sprache
Itemgruppen: 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 2, Day 1-2) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 16 Itemgruppen, 123 Datenelemente, 1 Sprache
Itemgruppen: 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 2, Day 3-6) - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 5 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Vital Signs Day 3-6, 12-Lead Electrocardiogram Day 3-6, FEV1 Day 3-6, 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

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