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Eligibility Rhinitis, Allergic NCT01104012

- 6/22/21 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis; ODM derived from: https://clinicaltrials.gov/show/NCT01104012

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

- 3/11/21 - 1 form, 4 itemgroups, 19 items, 1 language
Itemgroups: Total Nasal Symptom Scores, VAS, Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
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 - 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 - Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events

- 3/9/21 - 1 form, 13 itemgroups, 87 items, 1 language
Itemgroups: Logs and Repeats - Date of visit/assessment, Logs and Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Serious, Serious Adverse Event - Relevant Concomitant/Treatment Medications, Serious Adverse Event - Relevant Medical Conditions/Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Investigational Products, Serious Adverse Event - General Narrative Comments, Serious Adverse Event - No clinical
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 - Follow-Up - Pregnancy Information; Status of Treatment Blind, Study Conclusion

- 3/2/21 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Pregnancy Information, Status of Treatment Blind, Study Conclusion
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 - Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

- 3/2/21 - 1 form, 11 itemgroups, 38 items, 1 language
Itemgroups: Date of Visit, 12-Lead ECG/ Holter/ Telemetry ECG, Vital Signs, Pulmonary Function Tests, Local Laboratory - Haematology, Local Laboratory - Haematology , Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Urinalysis - Local, Urinalysis - Local: Dipstick Details, Urinalysis - Local: Microscopy Details
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 - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection

- 3/2/21 - 1 form, 15 itemgroups, 64 items, 1 language
Itemgroups: Inform Screening, Inform Enrolment, Date of Visit, Demography, 12-Lead ECG, Vital Signs - Measurement 1, Vital Signs - Measurement 2 and 3 , Local Laboratory - Haematology, Local Laboratory - Haematology , Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Urinalysis - Local, Urinalysis - Local: Dipstick Details, Urinalysis - Local: Microscopy Details, 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 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 - 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 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product

- 2/25/21 - 1 form, 9 itemgroups, 29 items, 1 language
Itemgroups: Date of Visit, Randomisation Number (Vsit 1), Vital Signs - Challenge Date and Time (Visit 1, 3, 5), Vital Signs - Start of Challenge (Visit 1, 3, 5), Nasal Inspection (Visit 1, 3, 5), Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5), Investigational Product (Dose) - Challenge Date and Time (Visit 1, 3, 5), Investigational Product - Date/time of dose (Visit 1, 3, 5), Investigational Product - Treatment Confirmation (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 - Eligibility Question; Subject Identification

- 2/22/21 - 1 form, 2 itemgroups, 2 items, 1 language
Itemgroups: Eligibility Question, Subject Identification
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

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