ID
29605
Descripción
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 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.
Link
https://clinicaltrials.gov/ct2/show/NCT00318630
Palabras clave
Versiones (2)
- 10/4/18 10/4/18 - Sarah Riepenhausen
- 10/4/18 10/4/18 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
10 de abril de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630
Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)
Descripción
Exhaled nitric oxide
Alias
- UMLS CUI-1
- C3700245 (undefined)
Descripción
Exhaled nitric oxide - Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3700245 (undefined)
- UMLS CUI [1,2]
- C0011008 (Date in time)
- SNOMED
- 410671006
Descripción
Planned relative time
Tipo de datos
text
Descripción
Actual Time of First Reading
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C3700245 (undefined)
- UMLS CUI [1,2]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
Descripción
Reading 1
Tipo de datos
float
Unidades de medida
- ppb
Alias
- UMLS CUI [1,1]
- C3700245 (undefined)
- UMLS CUI [1,2]
- C0456984 (Test Result)
- SNOMED
- 277775005
Descripción
Reading 2
Tipo de datos
float
Unidades de medida
- ppb
Alias
- UMLS CUI [1,1]
- C3700245 (undefined)
- UMLS CUI [1,2]
- C0456984 (Test Result)
- SNOMED
- 277775005
Descripción
Reading 3
Tipo de datos
float
Unidades de medida
- ppb
Alias
- UMLS CUI [1,1]
- C3700245 (undefined)
- UMLS CUI [1,2]
- C0456984 (Test Result)
- SNOMED
- 277775005
Descripción
Pulmonary function tests / FEV 1
Alias
- UMLS CUI-1
- C0024119 (Pulmonary function tests)
- SNOMED
- 23426006
- UMLS CUI-2
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
Date of FEV1
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008 (Date in time)
- SNOMED
- 410671006
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
Time relative to dosing
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439564 (Relative time)
- SNOMED
- 118578006
- LOINC
- LP21276-8
- UMLS CUI [1,2]
- C0748133 (PULMONARY FUNCTION TEST FEV1)
Descripción
Pulmonary Function Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
- UMLS CUI [1,2]
- C0024119 (Pulmonary function tests)
- SNOMED
- 23426006
Descripción
FEV1 Reading 1
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984 (Test Result)
- SNOMED
- 277775005
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
FEV1 Reading 2
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984 (Test Result)
- SNOMED
- 277775005
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
FEV1 Reading 3
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984 (Test Result)
- SNOMED
- 277775005
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
Value A in investigator Calculation
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984 (Test Result)
- SNOMED
- 277775005
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
Value B in Investigator Calculation
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0748133 (PULMONARY FUNCTION TEST FEV1)
- UMLS CUI [1,2]
- C0086715 (Normal Range)
- SNOMED
- 260395002
Descripción
Investigator Calculation: A / B x 100 FEV1 must be > 70% of predicted at Screening.
Tipo de datos
float
Unidades de medida
- %
Alias
- UMLS CUI [1]
- C0730561 (Percent predicted FEV1)
- SNOMED
- 313223002
Descripción
Pulmonary function tests: Pre-AMP Challenge
Alias
- UMLS CUI-1
- C0024119 (Pulmonary function tests)
- SNOMED
- 23426006
- UMLS CUI-2
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
- UMLS CUI-3
- C3812758 (Pre-dose Measure)
Descripción
pre-AMP pulmonary function test date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008 (Date in time)
- SNOMED
- 410671006
- UMLS CUI [1,2]
- C0024119 (Pulmonary function tests)
- SNOMED
- 23426006
- UMLS CUI [1,3]
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
- UMLS CUI [1,4]
- C3812758 (Pre-dose Measure)
Descripción
Time relative to start of challenge. 3 pre-saline measurements are required.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439564 (Relative time)
- SNOMED
- 118578006
- LOINC
- LP21276-8
- UMLS CUI [1,2]
- C0748133 (PULMONARY FUNCTION TEST FEV1)
Descripción
Time of FEV1
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
FEV1 Reading
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984 (Test Result)
- SNOMED
- 277775005
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
Pulmonary function tests: AMP Challenge
Alias
- UMLS CUI-1
- C0024119 (Pulmonary function tests)
- SNOMED
- 23426006
- UMLS CUI-2
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
Descripción
AMP-Challenge Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008 (Date in time)
- SNOMED
- 410671006
- UMLS CUI [1,2]
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
Descripción
Inhaled Substance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205535 (Inhalation Route of Drug Administration)
- LOINC
- LA9427-1
- UMLS CUI [1,2]
- C0001465 (adenosine monophosphate)
- SNOMED
- 4864008
- UMLS CUI [2,1]
- C0205535 (Inhalation Route of Drug Administration)
- LOINC
- LA9427-1
- UMLS CUI [2,2]
- C0036082 (Saline Solution)
- SNOMED
- 373757009
- LOINC
- LP31577-7
Descripción
Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. 0.000 is the concentration value for saline.
Tipo de datos
text
Unidades de medida
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561 (Concentration measurement)
- LOINC
- LP6194-7
- UMLS CUI [1,2]
- C0001465 (adenosine monophosphate)
- SNOMED
- 4864008
Descripción
Use this item, if historical concentrations instead of the concentrations given in the item "challenge concentration (New Subjects)" are used. Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.
Tipo de datos
float
Unidades de medida
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561 (Concentration measurement)
- LOINC
- LP6194-7
- UMLS CUI [1,2]
- C0001465 (adenosine monophosphate)
- SNOMED
- 4864008
Descripción
Fill in only for saline inhalation.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1301880 (Start time)
- SNOMED
- 398201009
- LOINC
- LP102339-1
- UMLS CUI [1,2]
- C0001559 (Inhalation Drug Administration)
- SNOMED
- 243132000
Descripción
Stop Time of Inhalation
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314 (End Time)
- SNOMED
- 397898000
- UMLS CUI [1,2]
- C0001559 (Inhalation Drug Administration)
- SNOMED
- 243132000
Descripción
Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439564 (Relative time)
- SNOMED
- 118578006
- LOINC
- LP21276-8
- UMLS CUI [1,2]
- C0205535 (Inhalation Route of Drug Administration)
- LOINC
- LA9427-1
- UMLS CUI [1,3]
- C0748133 (PULMONARY FUNCTION TEST FEV1)
Descripción
Pulmonary function time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
Descripción
FEV1 Result
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI [1,2]
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
Descripción
Pulmonary function tests: Post-AMP Challenge
Alias
- UMLS CUI-1
- C0231921 (Pulmonary function)
- SNOMED
- 106053004
- LOINC
- LP99358-1
- UMLS CUI-2
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
- UMLS CUI-3
- C0439568 (Post-dose)
- SNOMED
- 255566006
Descripción
Date of post-challenge FEV1
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008 (Date in time)
- SNOMED
- 410671006
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI [1,3]
- C0439568 (Post-dose)
- SNOMED
- 255566006
Descripción
Time relative to end of challenge: Post-challenge 6 measurements are required.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
- UMLS CUI [1,2]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI [1,3]
- C0439568 (Post-dose)
- SNOMED
- 255566006
Descripción
Record use of rescue Salbutamol on the Concomitant Medications page.
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI [1,2]
- C1274040 (Result)
- SNOMED
- 394617004
- UMLS CUI [1,3]
- C0439568 (Post-dose)
- SNOMED
- 255566006
Descripción
PC20 (AMP Challenge)
Alias
- UMLS CUI-1
- C1446561 (Concentration measurement)
- LOINC
- LP6194-7
- UMLS CUI-2
- C0001465 (adenosine monophosphate)
- SNOMED
- 4864008
- UMLS CUI-3
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI-4
- C0547047 (Decrease)
- SNOMED
- 260370003
Descripción
Date of challenge
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008 (Date in time)
- SNOMED
- 410671006
- UMLS CUI [1,2]
- C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
Descripción
Provocative concentration resulting in a 20% reduction in FEV1.
Tipo de datos
float
Unidades de medida
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561 (Concentration measurement)
- LOINC
- LP6194-7
- UMLS CUI [1,2]
- C0001465 (adenosine monophosphate)
- SNOMED
- 4864008
- UMLS CUI [2,1]
- C0429706 (Forced expiratory volume in 1 second finding)
- SNOMED
- 59328004
- UMLS CUI [2,2]
- C0547047 (Decrease)
- SNOMED
- 260370003
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C0439568 (UMLS CUI [1,3])
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