ID
44564
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 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.
Link
https://clinicaltrials.gov/ct2/show/NCT00318630
Palabras clave
Versiones (2)
- 10/4/18 10/4/18 - Sarah Riepenhausen
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2021
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 5 - Pulmonary function: Methacholine and Asthma-allergen challenge
Descripción
Pulmonary function tests: Methacholine Challenge
Alias
- UMLS CUI-1
- C0748133
- UMLS CUI-2
- C0430567
Descripción
Methacholine Challenge Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0748133
- UMLS CUI [1,3]
- C0430567
Descripción
Inhaled Substance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Descripción
Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of Methacoline (provocholine) until a ≥20 percent 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]
- C0600370
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 Methacholine (provocholine) 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
- UMLS CUI [1,2]
- C0600370
Descripción
Fill in only for saline inhalation and new subjects.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Descripción
Stop Time of Inhalation
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
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
Descripción
Pulmonary function time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Descripción
FEV1 Result
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0430567
Descripción
Pulmonary function tests: Post-Methacholine Challenge
Alias
- UMLS CUI-1
- C0231921
- UMLS CUI-2
- C0430567
- UMLS CUI-3
- C0439568
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
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
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
Descripción
PC20 (Methacholine Challenge)
Alias
- UMLS CUI-1
- C1446561
- UMLS CUI-2
- C0600370
- UMLS CUI-3
- C0429706
- UMLS CUI-4
- C0547047
Descripción
Date of challenge
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0430567
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
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0429706
- UMLS CUI [2,2]
- C0547047
Descripción
Skin Prick Test
Alias
- UMLS CUI-1
- C0430561
Descripción
Fill out once.
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0430561
Descripción
Time results read
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0430561
Descripción
Allergen used
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0430561
Descripción
Response
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0430561
Descripción
Wheal
Tipo de datos
float
Unidades de medida
- mm
Alias
- UMLS CUI [1]
- C3827475
Descripción
allergen usage in challenge
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0006265
Descripción
Pulmonary function tests: pre-asthma-allergen challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439565
Descripción
pre-asthma-allergen pulmonary function test date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024119
- UMLS CUI [1,3]
- C0006265
- UMLS CUI [1,4]
- C0002092
- UMLS CUI [1,5]
- C3812758
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
Descripción
Time of FEV1
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Descripción
FEV1 Reading
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Descripción
Pulmonary function tests: asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
Descripción
asthma-allergen challenge date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Descripción
Inhaled Substance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Descripción
Baseline FEV1 measurements were first taken using saline. During the challenge at screening the final concentration of allergen was determined when a fall in FEV1 of >15percent from the baseline value was achieved. 0.000 is the concentration value for saline.
Tipo de datos
text
Unidades de medida
- SQU/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Descripción
Fill in only for saline inhalation.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Descripción
Stop Time of Inhalation
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Descripción
Time relative to stop time of inhalation. Timepoints 2, 3 and 4 minutes postinhalation are only to be used for post-saline-inhalation (all three have to be done); 5 and 10 minutes post-inhalation are only for post-allergen-inhalation measurements (both have to be done for each allergen concentration).
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Descripción
Pulmonary function time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Descripción
FEV1 Result
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Descripción
Pulmonary function tests: Post-asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439568
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
Descripción
Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Descripción
Time of post-challenge FEV1
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Descripción
Reading 1 of post-challenge FEV1
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Descripción
Not to be done for timepoints 15, 20, 30 and 45 mins.
Tipo de datos
float
Unidades de medida
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
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Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge
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