ID
44564
Beschreibung
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
Stichworte
Versionen (2)
- 10.04.18 10.04.18 - Sarah Riepenhausen
- 27.09.21 27.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. September 2021
DOI
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Lizenz
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
Beschreibung
Pulmonary function tests: Methacholine Challenge
Alias
- UMLS CUI-1
- C0748133
- UMLS CUI-2
- C0430567
Beschreibung
Methacholine Challenge Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0748133
- UMLS CUI [1,3]
- C0430567
Beschreibung
Inhaled Substance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beschreibung
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.
Datentyp
text
Maßeinheiten
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beschreibung
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.
Datentyp
float
Maßeinheiten
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
Beschreibung
Fill in only for saline inhalation and new subjects.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschreibung
Stop Time of Inhalation
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschreibung
Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beschreibung
Pulmonary function time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschreibung
FEV1 Result
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0430567
Beschreibung
Pulmonary function tests: Post-Methacholine Challenge
Alias
- UMLS CUI-1
- C0231921
- UMLS CUI-2
- C0430567
- UMLS CUI-3
- C0439568
Beschreibung
Date of post-challenge FEV1
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschreibung
Time relative to end of challenge: Post-challenge 6 measurements are required.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschreibung
Record use of rescue Salbutamol on the Concomitant Medications page.
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beschreibung
PC20 (Methacholine Challenge)
Alias
- UMLS CUI-1
- C1446561
- UMLS CUI-2
- C0600370
- UMLS CUI-3
- C0429706
- UMLS CUI-4
- C0547047
Beschreibung
Date of challenge
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0430567
Beschreibung
Provocative concentration resulting in a 20% reduction in FEV1.
Datentyp
float
Maßeinheiten
- mg/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0600370
- UMLS CUI [2,1]
- C0429706
- UMLS CUI [2,2]
- C0547047
Beschreibung
Skin Prick Test
Alias
- UMLS CUI-1
- C0430561
Beschreibung
Fill out once.
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0430561
Beschreibung
Time results read
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0430561
Beschreibung
Allergen used
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0430561
Beschreibung
Response
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0430561
Beschreibung
Wheal
Datentyp
float
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C3827475
Beschreibung
allergen usage in challenge
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0002092
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0006265
Beschreibung
Pulmonary function tests: pre-asthma-allergen challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439565
Beschreibung
pre-asthma-allergen pulmonary function test date
Datentyp
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
Beschreibung
Time relative to start of challenge. 3 pre-saline measurements are required.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0748133
Beschreibung
Time of FEV1
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschreibung
FEV1 Reading
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschreibung
Pulmonary function tests: asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
Beschreibung
asthma-allergen challenge date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beschreibung
Inhaled Substance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205535
- UMLS CUI [1,2]
- C0002092
- UMLS CUI [2,1]
- C0205535
- UMLS CUI [2,2]
- C0036082
Beschreibung
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.
Datentyp
text
Maßeinheiten
- SQU/mL
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Beschreibung
Fill in only for saline inhalation.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschreibung
Stop Time of Inhalation
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschreibung
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).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
- UMLS CUI [1,3]
- C0748133
Beschreibung
Pulmonary function time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschreibung
FEV1 Result
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C0006265
- UMLS CUI [1,3]
- C0002092
Beschreibung
Pulmonary function tests: Post-asthma-allergen Challenge
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0006265
- UMLS CUI-3
- C0002092
- UMLS CUI-4
- C0439568
Beschreibung
Date of post-challenge FEV1
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschreibung
Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschreibung
Time of post-challenge FEV1
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
- UMLS CUI [1,3]
- C0439568
Beschreibung
Reading 1 of post-challenge FEV1
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Beschreibung
Not to be done for timepoints 15, 20, 30 and 45 mins.
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0429706
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0439568
Ähnliche Modelle
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])