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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

- 3/11/21 - 1 form, 13 itemgroups, 80 items, 1 language
Itemgroups: Concomitant Medication, 12-Lead ECG/ Holter/ Telemetry ECG, ECG Abnormalities, Vital Signs, Local Laboratory, Local Laboratory - Haematology , Local Laboratory - Clinical Chemistry, Urinalysis - Local, Urinalysis - Local: Dipstick Details, Urinalysis - Local: Microscopy Details, Pulmonary Function Tests, Nasal Airflow Resistance, Nasal Inspection
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 2/15/21 - 1 form, 15 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy
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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number

- 1/22/21 - 1 form, 16 itemgroups, 57 items, 1 language
Itemgroups: Administrative, Vital Signs - Pre-Dose, 12-Lead ECG (Pre-Dose), 12-Lead ECG Abnormalities , 12-Lead ECG Abnormalities, Pulmonary Function Tests (Pre-Dose), Pharmacodynamics - Blood Sample (Pre-Dose), Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis Microscopy Test, Urinalysis Microscopy Test, Randomisation Number
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 and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 1, Cohort 1: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 1), Local Laboratory - Haematology (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Local Laboratory - Clinical Chemistry (Period 1), Investigational Product (Dose) (Period 1), ECG (Period 1), Vital Signs (Period 1), Local Laboratory - Haematology (24Hr Lab) (Period 1), Local Laboratory - Haematology (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Blood (Period 1), Pharmacokinetics Urine (Period 1), Pharmacokinetics Urine (Period 1), Summary Holter (Period 1), Summary Holter (Period 1) (Pre-Dose - 24 hours), Holter Abnormalities (Period 1), Holter Abnormalities (Period 1), Pulmonary Function Tests (Period 1)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 2, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

- 1/2/21 - 1 form, 16 itemgroups, 52 items, 1 language
Itemgroups: Date of visit, Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Investigational Product (Dose) (Part 2 Period 4), ECG (Part 2 Period 4), ECG (Part 2 Period 4), Vital Signs (Part 2 Period 4), Vital Signs (Part 2 Period 4), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 2, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 2), ECG (Part 2 Period 2), ECG (Part 2 Period 2), Vital Signs (Part 2 Period 2), Vital Signs (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Pulmonary Function Tests (Part 2 Period 2), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 2), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Blood (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Pharmacokinetics Urine (Part 2 Period 2), Summary Holter (Part 2 Period 2), Summary Holter (Part 2 Period 2) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 2), Holter Abnormalities (Part 2 Period 2)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 3, Cohort 1: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

- 1/2/21 - 1 form, 16 itemgroups, 52 items, 1 language
Itemgroups: Date of visit, Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Investigational Product (Dose) (Part 2 Period 4), ECG (Part 2 Period 4), ECG (Part 2 Period 4), Vital Signs (Part 2 Period 4), Vital Signs (Part 2 Period 4), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 1/2/21 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 3, Cohort 2: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 1/2/21 - 1 form, 21 itemgroups, 84 items, 1 language
Itemgroups: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 2 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

- 12/30/20 - 1 form, 16 itemgroups, 52 items, 1 language
Itemgroups: Date of visit, Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Haematology (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Local Laboratory - Clinical Chemistry (Part 2 Period 4), Investigational Product (Dose) (Part 2 Period 4), ECG (Part 2 Period 4), ECG (Part 2 Period 4), Vital Signs (Part 2 Period 4), Vital Signs (Part 2 Period 4), Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4), Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4), Pulmonary Function Tests (Part 2 Period 4)
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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 2 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 12/30/20 - 1 form, 20 itemgroups, 72 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4)
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

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