ID

29657

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 Pharmacodynamics. Time: Treatment period 2, Day 14. Part 1: Blood and AMP Challenge

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Palabras clave

Versiones (1)
  1. 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
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Pharmacodynamics - Treatment period 2, Day 14, Part 1

1 formularios  
Blood
Descripción

Blood

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005834
Date sample Taken
Descripción

If sample is missed or lost, write "NA". Sample Number: 202

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C1277698
Actual Time sample taken
Descripción

Hr : Min (00:00 - 23:59) Time relative to dosing: Pre-dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Pulmonary function tests: Pre-AMP Challenge
Descripción

Pulmonary function tests: Pre-AMP Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C1096479
UMLS CUI-3
C3812758
pre-AMP pulmonary function test date
Descripción

pre-AMP pulmonary function test date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
UMLS CUI [1,3]
C1096479
UMLS CUI [1,4]
C3812758
Planned relative Time
Descripción

Time relative to start of challenge. 3 pre-saline measurements are required.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Time of FEV1
Descripción

Time of FEV1

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
FEV1 Reading
Descripción

FEV1 Reading

Tipo de datos

float

Unidades de medida
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Pulmonary function tests: AMP Challenge
Descripción

Pulmonary function tests: AMP Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C1096479
AMP-Challenge Date
Descripción

AMP-Challenge Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1096479
Inhaled Substance
Descripción

Inhaled Substance

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205535
UMLS CUI [1,2]
C0001465
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C0036082
Challenge Concentration
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
UMLS CUI [1,2]
C0001465
Start Time of Inhalation
Descripción

Fill in only for saline inhalation.

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0001559
Stop Time of Inhalation
Descripción

Stop Time of Inhalation

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0001559
Planned relative Time of FEV1
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
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0748133
Pulmonary function time
Descripción

Pulmonary function time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
FEV1 Result
Descripción

FEV1 Result

Tipo de datos

float

Unidades de medida
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C1096479
L
Pulmonary function tests: Post-AMP Challenge
Descripción

Pulmonary function tests: Post-AMP Challenge

Alias
UMLS CUI-1
C0231921
UMLS CUI-2
C1096479
UMLS CUI-3
C0439568
Date of post-challenge FEV1
Descripción

Date of post-challenge FEV1

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Time of post-challenge FEV1
Descripción

Time relative to end of challenge: Post-challenge 6 measurements are required.

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Result of post-challenge FEV1
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
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0439568
L
Volver a la parte superior de la página

Similar models

Pharmacodynamics - Treatment period 2, Day 14, Part 1

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Blood
C0851347 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Date sample Taken
Item
Date sample Taken
date
C1302413 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Time sample taken
Item
Actual Time sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: Pre-AMP Challenge
C0024119 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
pre-AMP pulmonary function test date
Item
pre-AMP pulmonary function test date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1096479 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,4])
Item
Planned relative Time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative Time
CL Item
pre-saline (pre-saline)
CL Item
unscheduled (unscheduled)
Time of FEV1
Item
Time of FEV1
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading
Item
FEV1 Reading
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: AMP Challenge
C0024119 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
AMP-Challenge Date
Item
AMP-Challenge Date
date
C0011008 (UMLS CUI [1,1])
C1096479 (UMLS CUI [1,2])
Item
Inhaled Substance
text
C0205535 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
C0205535 (UMLS CUI [2,1])
C0036082 (UMLS CUI [2,2])
Inhaled Substance
Code List
Inhaled Substance
CL Item
Saline (Saline)
CL Item
Saline, unscheduled (Saline, unscheduled)
CL Item
AMP (AMP)
Item
Challenge Concentration
text
C1446561 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
Challenge Concentration (New Subjects)
Code List
Challenge Concentration
CL Item
0.000 (0.000)
CL Item
0.039 (0.039)
CL Item
0.078 (0.078)
CL Item
0.156 (0.156)
CL Item
0.3125 (0.3125)
CL Item
0.625 (0.625)
CL Item
1.25 (1.25)
CL Item
2.5 (2.5)
CL Item
5 (5)
CL Item
10 (10)
CL Item
20 (20)
CL Item
40 (40)
CL Item
80 (80)
CL Item
160 (160)
CL Item
320 (320)
Start Time of Inhalation
Item
Start Time of Inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Stop Time of Inhalation
Item
Stop Time of Inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Item
Planned relative Time of FEV1
text
C0439564 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Planned relative Time of FEV1
Code List
Planned relative Time of FEV1
CL Item
60 secs post-inhalation (60 secs post-inhalation)
CL Item
180 secs post-inhalation (180 secs post-inhalation)
Pulmonary function time
Item
Pulmonary function time
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Result
Item
FEV1 Result
float
C0429706 (UMLS CUI [1,1])
C1096479 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: Post-AMP Challenge
C0231921 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of post-challenge FEV1
Item
Date of post-challenge FEV1
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Time of post-challenge FEV1
Item
Time of post-challenge FEV1
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Result of post-challenge FEV1
Item
Result of post-challenge FEV1
float
C0429706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial