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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Running Logs and End of Study - Non-Serious Adverse Events; Serious Adverse Event

- 2021-01-19 - 1 Formulär, 18 Item-grupper, 59 Dataelement, 1 Språk
Item-grupper: Administrative, Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 1 , Serious Adverse Event - Section 2 (Seriousness), Serious Adverse Event - Section 3 (Demography Data), Serious Adverse Event - Section 4, Serious Adverse Event - Section 5, Serious Adverse Event - Section 6 (Relevant Medical Conditions), Serious Adverse Event - Section 7, Serious Adverse Event - Section 8 (Concomitant Medication), Serious Adverse Event - Section 9 (Details of Investigational Product(s)), Serious Adverse Event - Section 9 (Details of Investigational Product(s)) , Serious Adverse Event - Section 10, Serious Adverse Event - Section 11, Investigator's signature
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) - Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

- 2021-01-13 - 1 Formulär, 8 Item-grupper, 30 Dataelement, 1 Språk
Item-grupper: Administrative, Status of Treatment Blind, Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research, Pharmacogenetic Research - Blood Sample Collection (DNA), Pharmacogenetic Research - Withdrawal of consent, Pharmacogenetic Research - Blood Sample Destruction, Concomitant Medications, Concomitant Medications
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) - Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C

- 2021-01-12 - 1 Formulär, 19 Item-grupper, 32 Dataelement, 1 Språk
Item-grupper: Administrative, Serious Adverse Event, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis - Microscopy, Urinalysis - Microscopy , Local Laboratory - Unscheduled Clinical Chemistry, Local Laboratory - Unscheduled Clinical Chemistry , Local Laboratory - Unscheduled Haematology, Local Laboratory - Unscheduled Haematology , Unscheduled Urinalysis - Local, Unscheduled Urinalysis - Local, Urinalysis - Microscopy (Unscheduled), Urinalysis - Microscopy (Unscheduled) , Serology - Screen for HIV Antibody and Hepatitis B&C
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) - Eligibility Question

- 2021-01-12 - 1 Formulär, 4 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Administrative, Eligibility Question, Inclusion Criteria, Exclusion Criteria
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) - Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

- 2021-01-09 - 1 Formulär, 6 Item-grupper, 36 Dataelement, 1 Språk
Item-grupper: Administrative, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities , Pulmonary Function Tests, Inhaler Device Training
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) - Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

- 2021-01-07 - 1 Formulär, 7 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: Administrative, Alcohol Intake, Alcohol Breath Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Urine Cotinine Test, History of Tobacco Use
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) - Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

- 2021-01-06 - 1 Formulär, 8 Item-grupper, 25 Dataelement, 1 Språk
Item-grupper: Administrative, Demography, Child-Bearing Potential, Pregnancy Test, Physical Examination, Vital Signs, Vital Signs , Medical Conditions
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

Eligibility Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia NCT01216215

- 2020-06-13 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Novel Gentic Variations Contributing to Asthma Susceptability in Saudi Arabia; ODM derived from: https://clinicaltrials.gov/show/NCT01216215

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Screening Visit: Vital Signs Form

- 2020-04-30 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - SAE Status

- 2020-04-30 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: SAE Status
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Electronically Transferred Lab Data

- 2020-04-30 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: Electronically Transferred Lab Data
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Alcohol Intake at Onset of Liver Event (Liver Alcohol)

- 2020-04-30 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: Alcohol Intake at Onset of Liver Event
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

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