ID
44564
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00318630
Nyckelord
Versioner (2)
- 2018-04-10 2018-04-10 - Sarah Riepenhausen
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2021
DOI
För en begäran logga in.
Licens
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
Beskrivning
Pulmonary function tests: Methacholine Challenge
Alias
- UMLS CUI-1
- C0748133
- UMLS CUI-2
- C0430567
Beskrivning
Methacholine Challenge Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0748133
- UMLS CUI [1,3]
- C0430567
Beskrivning
Inhaled Substance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beskrivning
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.
Datatyp
text
Måttenheter
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beskrivning
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.
Datatyp
float
Måttenheter
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beskrivning
Fill in only for saline inhalation and new subjects.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beskrivning
Stop Time of Inhalation
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beskrivning
Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beskrivning
Pulmonary function time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beskrivning
FEV1 Result
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0430567
Beskrivning
Pulmonary function tests: Post-Methacholine Challenge
Alias
- UMLS CUI-1
- C0231921
- UMLS CUI-2
- C0430567
- UMLS CUI-3
- C0439568
Beskrivning
Date of post-challenge FEV1
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beskrivning
Time relative to end of challenge: Post-challenge 6 measurements are required.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beskrivning
Record use of rescue Salbutamol on the Concomitant Medications page.
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beskrivning
PC20 (Methacholine Challenge)
Alias
- UMLS CUI-1
- C1446561
- UMLS CUI-2
- C0600370
- UMLS CUI-3
- C0429706
- UMLS CUI-4
- C0547047
Beskrivning
Date of challenge
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0430567
Beskrivning
Provocative concentration resulting in a 20% reduction in FEV1.
Datatyp
float
Måttenheter
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0429706
- UMLS CUI [2,2]
- C0547047
Beskrivning
Skin Prick Test
Alias
- UMLS CUI-1
- C0430561
Beskrivning
Fill out once.
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0430561
Beskrivning
Time results read
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0430561
Beskrivning
Allergen used
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0430561
Beskrivning
Response
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0430561
Beskrivning
Wheal
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C3827475
Beskrivning
allergen usage in challenge
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0006265
Beskrivning
Pulmonary function tests: pre-asthma-allergen challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439565
Beskrivning
pre-asthma-allergen pulmonary function test date
Datatyp
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
Beskrivning
Time relative to start of challenge. 3 pre-saline measurements are required.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0748133
Beskrivning
Time of FEV1
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beskrivning
FEV1 Reading
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beskrivning
Pulmonary function tests: asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
Beskrivning
asthma-allergen challenge date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beskrivning
Inhaled Substance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beskrivning
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.
Datatyp
text
Måttenheter
- SQU/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Beskrivning
Fill in only for saline inhalation.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beskrivning
Stop Time of Inhalation
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beskrivning
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).
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beskrivning
Pulmonary function time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beskrivning
FEV1 Result
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beskrivning
Pulmonary function tests: Post-asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439568
Beskrivning
Date of post-challenge FEV1
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beskrivning
Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beskrivning
Time of post-challenge FEV1
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beskrivning
Reading 1 of post-challenge FEV1
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beskrivning
Not to be done for timepoints 15, 20, 30 and 45 mins.
Datatyp
float
Måttenheter
- 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])