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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  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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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge

- 9/27/21 - 1 form, 8 itemgroups, 41 items, 1 language
Itemgroups: Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge, PC20 (Methacholine Challenge), Skin Prick Test, Pulmonary function tests: pre-asthma-allergen challenge, Pulmonary function tests: asthma-allergen Challenge, Pulmonary function tests: Post-asthma-allergen 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 Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

- 9/20/21 - 1 form, 10 itemgroups, 72 items, 2 languages
Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch
Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit (Undefined)

- 9/20/21 - 4 forms, 10 itemgroups, 72 items, 2 languages
Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch
Study documentation part: Outpatient Department Visit (Undefined and with microbiology part). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Microbiology- Staphylococcus aureus characteristics

5 itemgroups 29 items

Microbiology- Summary sheet

4 itemgroups 23 items

Microbiology- Sputum, Serum and EDTA blood

3 itemgroups 13 items

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

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 2, 4, 6 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 2/25/21 - 1 form, 21 itemgroups, 59 items, 1 language
Itemgroups: Date of Visit, Challenge Date and Time (0-4 Hr), Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Pulmonary Function Tests - 3 hr Post Challenge Start, Pulmonary Function Tests - 4 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Start of Challenge, Nasal Allergen Challenge, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions, VAS - Challenge Date and Time, VAS - Dosing Date and Time, VAS - Start of Challenge, VAS
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

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 2/25/21 - 1 form, 25 itemgroups, 68 items, 1 language
Itemgroups: Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5), Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5), Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5), Nasal Allergen Challenge (Visit 1, 3, 5), Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5), Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5), Nasal Airflow Resistance (Visit 1, 3, 5), Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5), Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5), Nasal Secretions - Start of Challenge (Visit 1, 3, 5), Nasal Secretions (Visit 1, 3, 5), VAS - Challenge Date and Time (Visit 1, 3, 5), VAS - Dosing Date and Time (Visit 1, 3, 5), VAS - Start of Challenge (Visit 1, 3, 5), VAS (Visit 1, 3, 5)
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

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Screening - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 2/19/21 - 1 form, 17 itemgroups, 48 items, 1 language
Itemgroups: Challenge Date and Time, Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Pre-Dose, Nasal Allergen Challenge - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance - 1 Hr 30 Min Post Challenge, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions - 1 Hr and 2 Hr Post-Challenge Start , VAS - Challenge Date and Time, VAS - Pre-Dose, VAS - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr
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) - Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test

- 2/8/21 - 1 form, 11 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Investigational Product Day 1 - 7, Treatment Corfirmation Day 1 - 7, Carbon Monoxide Test - Day 6 PM, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Vital Signs - Day 7, 12-Lead ECG - Day 7, 12-Lead ECG Abnormalities - Day 7, 12-Lead ECG Abnormalities - Day 7, Pulmonary Function Test - Day 7
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

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

- 1/9/21 - 1 form, 6 itemgroups, 36 items, 1 language
Itemgroups: 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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 2, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

- 1/2/21 - 1 form, 33 itemgroups, 122 items, 1 language
Itemgroups: Date of visit, Investigational Product (Dose) (Part 2 Period 2), ECG, ECG - Day 2 Dose (Part 2 Period 2), ECG - Day 2 Dose (Part 2 Period 2, ECG - Day 3 Dose (Part 2 Period 2), ECG - Day 3 Dose (Part 2 Period 2), ECG - Day 4 Dose (Part 2 Period 2), ECG - Day 4 Dose (Part 2 Period 2), ECG - Day 5 Dose (Part 2 Period 2), ECG - Day 5 Dose (Part 2 Period 2), ECG - Day 6 Dose (Part 2 Period 2), ECG - Day 6 Dose (Part 2 Period 2), Vital Signs - Day 2 Dose (Part 2 Period 2), Vital Signs - Day 2 Dose (Part 2 Period 2), Vital Signs - Day 3 Dose (Part 2 Period 2), Vital Signs - Day 3 Dose (Part 2 Period 2), Vital Signs - Day 4 Dose (Part 2 Period 2), Vital Signs - Day 4 Dose (Part 2 Period 2), Vital Signs - Day 5 Dose (Part 2 Period 2), Vital Signs - Day 5 Dose (Part 2 Period 2), Vital Signs - Day 6 Dose (Part 2 Period 2), Vital Signs - Day 6 Dose (Part 2 Period 2), Pulmonary Function Tests - Day 2 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 2), Pulmonary Function Tests - Day 3 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 2), Pulmonary Function Tests - Day 4 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 2), Pulmonary Function Tests - Day 5 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 2), Pulmonary Function Tests - Day 6 Dose (Part 2 Period 2), Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (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

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