ID
44564
Description
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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00318630
Mots-clés
Versions (2)
- 10/04/2018 10/04/2018 - Sarah Riepenhausen
- 27/09/2021 27/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
27 septembre 2021
DOI
Pour une demande vous connecter.
Licence
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
Description
Pulmonary function tests: Methacholine Challenge
Alias
- UMLS CUI-1
- C0748133
- UMLS CUI-2
- C0430567
Description
Methacholine Challenge Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0748133
- UMLS CUI [1,3]
- C0430567
Description
Inhaled Substance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Description
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.
Type de données
text
Unités de mesure
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Description
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.
Type de données
float
Unités de mesure
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Description
Fill in only for saline inhalation and new subjects.
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Description
Stop Time of Inhalation
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Description
Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Description
Pulmonary function time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Description
FEV1 Result
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0430567
Description
Pulmonary function tests: Post-Methacholine Challenge
Alias
- UMLS CUI-1
- C0231921
- UMLS CUI-2
- C0430567
- UMLS CUI-3
- C0439568
Description
Date of post-challenge FEV1
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Description
Time relative to end of challenge: Post-challenge 6 measurements are required.
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Description
Record use of rescue Salbutamol on the Concomitant Medications page.
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Description
PC20 (Methacholine Challenge)
Alias
- UMLS CUI-1
- C1446561
- UMLS CUI-2
- C0600370
- UMLS CUI-3
- C0429706
- UMLS CUI-4
- C0547047
Description
Date of challenge
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0430567
Description
Provocative concentration resulting in a 20% reduction in FEV1.
Type de données
float
Unités de mesure
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0429706
- UMLS CUI [2,2]
- C0547047
Description
Skin Prick Test
Alias
- UMLS CUI-1
- C0430561
Description
Fill out once.
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0430561
Description
Time results read
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0430561
Description
Allergen used
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0430561
Description
Response
Type de données
text
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0430561
Description
Wheal
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C3827475
Description
allergen usage in challenge
Type de données
text
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0006265
Description
Pulmonary function tests: pre-asthma-allergen challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439565
Description
pre-asthma-allergen pulmonary function test date
Type de données
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
Description
Time relative to start of challenge. 3 pre-saline measurements are required.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0748133
Description
Time of FEV1
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Description
FEV1 Reading
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Description
Pulmonary function tests: asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
Description
asthma-allergen challenge date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Description
Inhaled Substance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Description
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.
Type de données
text
Unités de mesure
- SQU/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Description
Fill in only for saline inhalation.
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Description
Stop Time of Inhalation
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Description
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).
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Description
Pulmonary function time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Description
FEV1 Result
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Description
Pulmonary function tests: Post-asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439568
Description
Date of post-challenge FEV1
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Description
Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Description
Time of post-challenge FEV1
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Description
Reading 1 of post-challenge FEV1
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Description
Not to be done for timepoints 15, 20, 30 and 45 mins.
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Similar models
Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge
C0430567 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0024119 (UMLS CUI [1,2])
C0430567 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,4])
C0748133 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0430567 (UMLS CUI-2)
C0748133 (UMLS CUI [1,2])
C0430567 (UMLS CUI [1,3])
C0600370 (UMLS CUI [1,2])
C0205535 (UMLS CUI [2,1])
C0036082 (UMLS CUI [2,2])
C0600370 (UMLS CUI [1,2])
C0600370 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C0205535 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0430567 (UMLS CUI [1,2])
C0430567 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0600370 (UMLS CUI-2)
C0429706 (UMLS CUI-3)
C0547047 (UMLS CUI-4)
C0430567 (UMLS CUI [1,2])
C0600370 (UMLS CUI [1,2])
C0429706 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0430561 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0430561 (UMLS CUI [1,3])
C0457083 (UMLS CUI [1,2])
C0006265 (UMLS CUI [1,3])
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
C0024119 (UMLS CUI [1,2])
C0006265 (UMLS CUI [1,3])
C0002092 (UMLS CUI [1,4])
C3812758 (UMLS CUI [1,5])
C0748133 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
C0006265 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,3])
C0002092 (UMLS CUI [1,2])
C0205535 (UMLS CUI [2,1])
C0036082 (UMLS CUI [2,2])
C0002092 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C0205535 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0006265 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,3])
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])