Keywords
Pulmonary Disease, Chronic Obstructive ×
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Table of contents
  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
  7. 7. Medical Specialty
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185 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

Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive - Eligibility

- 4/14/14 - 1 form, 2 itemgroups, 23 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00525512

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Demography

- 10/20/20 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Administrative data, Demography
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 (Demography) is to be filled out at the Screening (Visit 1).

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Inform Screening

- 10/20/20 - 1 form, 2 itemgroups, 22 items, 1 language
Itemgroups: Subject Identification, Are you willing to tell us how you learned about this study?
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 (Inform Screening) is to be filled out at the Screening (Visit 1).

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Eligibility

- 10/15/20 - 1 form, 4 itemgroups, 25 items, 1 language
Itemgroups: Administrative Data, Eligibility question, Inclusion Criteria, Exclusion Criteria
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 (Eligibility) is to be filled out at the Screening (Visit 1).

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) - 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) - 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) - 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)