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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Follow-Up Part 2 - Laboratory Results

- 10-04-18 - 1 Formulier, 2 Itemgroepen, 34 Data-elementen, 1 Taal
Itemgroepen: Laboratory result data - Haematology, Laboratory result data - Clinical chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Follow-Up Part 2: Laboratory Results.

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Status of Treatment Blind, Vital Signs, ECG, Study Conclusion, Pregnancy Information, Electronically Transferred Lab Data - Follow- Up

- 21-10-18 - 1 Formulier, 6 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Status of Treatment blind, Vital signs, 12 lead ECG, Study Conclusion, Pregnancy Information, Electronically transferred lab data
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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

- 15-02-21 - 1 Formulier, 15 Itemgroepen, 54 Data-elementen, 1 Taal
Itemgroepen: 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

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Unscheduled Laboratory Results

- 13-04-22 - 1 Formulier, 3 Itemgroepen, 55 Data-elementen, 2 Talen
Itemgroepen: Laboratory result data - Haematology, Laboratory result data - Clinical chemistry, Urinalysis
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Unscheduled Laboratory Results (Haematology, clinical chemistry, Urinalysis).

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

- 06-04-22 - 1 Formulier, 3 Itemgroepen, 35 Data-elementen, 1 Taal
Itemgroepen: Pregnancy Test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 14, Pre-dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 3 - Alcohol, Drugs, Tobacco and Laboratory Results

- 27-09-21 - 1 Formulier, 4 Itemgroepen, 77 Data-elementen, 1 Taal
Itemgroepen: Alcohol, drugs and tobacco, Laboratory result data - Haematology, Laboratory result data - Clinical chemistry, Urinalysis
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 3 - Alcohol, Drugs, Tobacco and Laboratory Results.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 1, Day 14, Part 2

- 10-04-18 - 1 Formulier, 6 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: Baseline FEV1 Measurement - Sputum Induction post-challenge, Sputum induction post-challenge, Sputum post-challenge sample, Sputum hemacytometry post-challenge, Sputum induction post-challenge summary, Sputum slide results post-challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics. Time: Treatment period 1, Day 14. Part 2: Sputum Induction.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 2, Day 14, Part 2

- 10-04-18 - 1 Formulier, 6 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: Baseline FEV1 Measurement - Sputum Induction post-challenge, Sputum induction post-challenge, Sputum post-challenge sample, Sputum hemacytometry post-challenge, Sputum induction post-challenge summary, Sputum slide results post-challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics. Time: Treatment period 2, Day 14. Part 2: Sputum Induction.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 1, Day 14, Pre-dose

- 10-04-18 - 1 Formulier, 3 Itemgroepen, 35 Data-elementen, 1 Taal
Itemgroepen: Pregnancy Test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 1, Day 14, Pre-Dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 1, Day 1

- 10-04-18 - 1 Formulier, 7 Itemgroepen, 60 Data-elementen, 1 Taal
Itemgroepen: Blood, Baseline FEV1 Measurement - Sputum Induction, Sputum induction (Supernatant), Sputum sample, Sputum hemacytometry, Sputum induction summary, Sputum slide results
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics: Blood, Sputum. Time: Treatment period 1, Day 1.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 2, Day 1

- 10-04-18 - 1 Formulier, 7 Itemgroepen, 60 Data-elementen, 1 Taal
Itemgroepen: Blood, Baseline FEV1 Measurement - Sputum Induction, Sputum induction (Supernatant), Sputum sample, Sputum hemacytometry, Sputum induction summary, Sputum slide results
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics: Blood, Sputum. Time: Treatment period 2, Day 1.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Unscheduled Assessments Form

- 06-12-18 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: Unscheduled Assessments
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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