ID

29515

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 Eligibility Criteria.

Link

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

Palabras clave

Versiones (2)
  1. 5/4/18 5/4/18 - Sarah Riepenhausen
  2. 27/9/21 27/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de abril de 2018

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

Inglés

Eligibility Criteria

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Eligibility Question
Descripción

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descripción

If no, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Tipo de datos

text

Alias
UMLS CUI [1]
C1302261
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Males and females aged 18 to 55 years inclusive. Females must be post-menopausal (e.g. >6 months without a menstrual period), surgically sterile, or using acceptable contraceptive measures (oral contraceptive, Norplant, Depo-Provera, an IUD, a diaphragm with spermicide or condoms).
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0700589
Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C2936789
Pre-bronchodilator FEV1 >70percent of predicted at screening.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3172227
No history of smoking within 6 months of the start of the study, and with a total pack year history of <10 pack years.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0453996
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1277691
Demonstration of a positive wheal and flare reaction (>3 mm relative to control) to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair) on skin prick testing at screening, or within 12 months of study start.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C0020517
Inhaled allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of >20percent from the post saline value, on at least one occasion, between 10 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of >15percent from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006265
UMLS CUI [1,2]
C0748133
Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20percent fall in FEV1 (PC20 AMP) of less than 100 mg/mL.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1096479
UMLS CUI [1,2]
C0748133
Documented sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20percent fall in FEV1 (PC20 methacholine) of <8 mg/mL or provocative dose of methacholine <3.2 mg (PD20 methacholine) resulting in a 20percent fall in FEV1.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0430567
Able and willing to give written informed consent to take part in the study.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Available to complete all study measurements.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
BMI 18.0-30.0 kg/m2 inclusive.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. Subjects with the following diseases should not be included in the study under any circumstances: oedema, diabetes mellitus, chronic bronchitis, tuberculosis, emphysema, bronchiectasis or pulmonary fibrosis.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0034069
UMLS CUI [2]
C0013604
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0008677
UMLS CUI [5]
C0041296
UMLS CUI [6]
C0034067
UMLS CUI [7]
C0006267
UMLS CUI [8]
C0034069
History of malignancy in the last 2 years except for surgically cured skin carcinoma or cervical dysplasia (CIN I-II).
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
Clinically significant abnormalities in safety laboratory analysis at screening Specifically, male subjects must not have serum creatinine >1.5mg/dL (133μmol/L) and female subjects must not have serum creatinine >1.4mg/dL (124μmol/L). ALT, AST, total bilirubin, GGT and alkaline phosphatase must not be >2.5 times the ULN.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0202035
UMLS CUI [6]
C0201850
Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0458827
History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0020440
UMLS CUI [4]
C0162297
UMLS CUI [5]
C1843573
Administration of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0419839
UMLS CUI [3]
C2825233
UMLS CUI [4]
C0304604
Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments (eg headache), from 48h before the first dose until the follow-up visit.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0003360
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0004096
UMLS CUI [5,1]
C2607914
UMLS CUI [5,2]
C0013227
UMLS CUI [6,1]
C0018621
UMLS CUI [6,2]
C0013227
The subject has participated in a study with a new molecular entity during the previous 3 months.
Descripción

If criterium does not apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
History of being unable to tolerate or complete allergen challenge tests.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006265
UMLS CUI [1,2]
C0002092
Subject is undergoing allergen desensitisation therapy.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162352
There is a risk of non-compliance with study medication or study procedures.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
History of blood donation (450 mL) within 2 months of starting the clinical study.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
Anaemia defined by a haemoglobin concentration <11 g/dL for males or <10 g/dL for females.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0518015
The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
The subject has a screening QTc value of >430 ms for males and >450 ms for females, PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave).
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4015677
UMLS CUI [2]
C0429087
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C3844399
The subject is infected with HIV, Hepatitis B or C virus.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
The subject has positive drugs of abuse test.
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373483
Any contraindication to the use of AVANDIA. This includes known hypersensitivity to rosiglitazone, cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment and use of insulin. Hepatic impairment is defined as ALT, AST, total bilirubin, GGT and alkaline phosphatase >2.5 times the ULN or cirrhosis (Childs-Pugh class B/C).
Descripción

If criterium does apply, do not enter subject into the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0289313
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0289313
UMLS CUI [3]
C1882083
UMLS CUI [4]
C0021641
UMLS CUI [5,1]
C0948807
UMLS CUI [5,2]
C1278039
UMLS CUI [5,3]
C0201836
UMLS CUI [5,4]
C0201899
UMLS CUI [5,5]
C0201850
UMLS CUI [5,6]
C2347612
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Similar models

Eligibility Criteria

1 formularios
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1302261 (UMLS CUI [1])
Eligibility
Code List
Did the subject meet all the entry criteria?
CL Item
yes (y)
CL Item
no (n)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age; post-menopausal, surgically sterile or contraceptive meassures
Item
Males and females aged 18 to 55 years inclusive. Females must be post-menopausal (e.g. >6 months without a menstrual period), surgically sterile, or using acceptable contraceptive measures (oral contraceptive, Norplant, Depo-Provera, an IUD, a diaphragm with spermicide or condoms).
boolean
C0001779 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Bronchial asthma over 6 months, only short-acting beta-agonist therapy
Item
Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
boolean
C0004096 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
Pre-bronchodilator FEV1
Item
Pre-bronchodilator FEV1 >70percent of predicted at screening.
boolean
C3172227 (UMLS CUI [1])
history of smoking, pack years
Item
No history of smoking within 6 months of the start of the study, and with a total pack year history of <10 pack years.
boolean
C0453996 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
Skin prick test positive
Item
Demonstration of a positive wheal and flare reaction (>3 mm relative to control) to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair) on skin prick testing at screening, or within 12 months of study start.
boolean
C0430561 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
early and late asthmatic response, FEV1 fall in allergen challenge
Item
Inhaled allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of >20percent from the post saline value, on at least one occasion, between 10 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of >15percent from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen.
boolean
C0006265 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
AMP challenge, FEV1
Item
Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20percent fall in FEV1 (PC20 AMP) of less than 100 mg/mL.
boolean
C1096479 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Metacholine challenge, FEV1
Item
Documented sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20percent fall in FEV1 (PC20 methacholine) of <8 mg/mL or provocative dose of methacholine <3.2 mg (PD20 methacholine) resulting in a 20percent fall in FEV1.
boolean
C0748133 (UMLS CUI [1,1])
C0430567 (UMLS CUI [1,2])
Informed consent
Item
Able and willing to give written informed consent to take part in the study.
boolean
C0021430 (UMLS CUI [1])
Availablity
Item
Available to complete all study measurements.
boolean
C1321605 (UMLS CUI [1])
BMI
Item
BMI 18.0-30.0 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Past or present disease possibly affecting study outcome: cardiovascular, hepatic, renal, haematological, neurological, endocrine, pulmonary; oedema, diabetes mellitus, chronic bronchitis, tuberculosis, emphysema, bronchiectasis, pulmonary fibrosis
Item
Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. Subjects with the following diseases should not be included in the study under any circumstances: oedema, diabetes mellitus, chronic bronchitis, tuberculosis, emphysema, bronchiectasis or pulmonary fibrosis.
boolean
C0034069 (UMLS CUI [1])
C0013604 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0008677 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
C0034067 (UMLS CUI [6])
C0006267 (UMLS CUI [7])
C0034069 (UMLS CUI [8])
Malignancy in last 2 years
Item
History of malignancy in the last 2 years except for surgically cured skin carcinoma or cervical dysplasia (CIN I-II).
boolean
C0006826 (UMLS CUI [1])
Serum creatinine, ALT, AST, totla bilirubin, GGT, alkaline phosphatase
Item
Clinically significant abnormalities in safety laboratory analysis at screening Specifically, male subjects must not have serum creatinine >1.5mg/dL (133μmol/L) and female subjects must not have serum creatinine >1.4mg/dL (124μmol/L). ALT, AST, total bilirubin, GGT and alkaline phosphatase must not be >2.5 times the ULN.
boolean
C0201976 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0202035 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
Repiratory tract infection, asthma exacerbation
Item
Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
boolean
C0349790 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0458827 (UMLS CUI [1,3])
life-threatening asthma: intubation, hypercapnoea, respiratory arrest, hypoxic seizures
Item
History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0020440 (UMLS CUI [3])
C0162297 (UMLS CUI [4])
C1843573 (UMLS CUI [5])
oral, injectable, dermal, intranasal or inhaled steroids close before screening visit
Item
Administration of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit.
boolean
C2065041 (UMLS CUI [1])
C0419839 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
C0304604 (UMLS CUI [4])
Unable to abstain from other medications: NSAID, anti-depressant, anti-histamines, anti-asthma, anti-rhinitis, anti-hayfever
Item
Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments (eg headache), from 48h before the first dose until the follow-up visit.
boolean
C0003211 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0003360 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0004096 (UMLS CUI [4,2])
C2607914 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0018621 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
Study participation with a new molecular entity during previous 3 months
Item
The subject has participated in a study with a new molecular entity during the previous 3 months.
boolean
C2348568 (UMLS CUI [1])
unable to tolerate or complete allergen challenge tests
Item
History of being unable to tolerate or complete allergen challenge tests.
boolean
C0006265 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
Allergen desensitization
Item
Subject is undergoing allergen desensitisation therapy.
boolean
C0162352 (UMLS CUI [1])
Non-compliance risk
Item
There is a risk of non-compliance with study medication or study procedures.
boolean
C1321605 (UMLS CUI [1])
Blood donation within last 2 months
Item
History of blood donation (450 mL) within 2 months of starting the clinical study.
boolean
C0005794 (UMLS CUI [1])
Anaemia, haemoglobin concentration
Item
Anaemia defined by a haemoglobin concentration <11 g/dL for males or <10 g/dL for females.
boolean
C0002871 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
alcohol consumption
Item
The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
boolean
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
QTc value, PR interval, unsuitable ECG (T-wave termination)
Item
The subject has a screening QTc value of >430 ms for males and >450 ms for females, PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave).
boolean
C4015677 (UMLS CUI [1])
C0429087 (UMLS CUI [2])
C1623258 (UMLS CUI [3,1])
C3844399 (UMLS CUI [3,2])
Infection with HIV, Hepatitis B or C virus
Item
The subject is infected with HIV, Hepatitis B or C virus.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
positive drugs of abuse test
Item
The subject has positive drugs of abuse test.
boolean
C0373483 (UMLS CUI [1])
Contraindications to study medication: hypersensitivity to rosiglitazone, cardiac failure (NYHA I-IV), use of insulin, hepatic impairment (ALT, AST, total bilirubin, GGT and alkaline phosphatase over 2,5 times ULN, cirrhosis/Child-Pugh B/C)
Item
Any contraindication to the use of AVANDIA. This includes known hypersensitivity to rosiglitazone, cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment and use of insulin. Hepatic impairment is defined as ALT, AST, total bilirubin, GGT and alkaline phosphatase >2.5 times the ULN or cirrhosis (Childs-Pugh class B/C).
boolean
C1301624 (UMLS CUI [1,1])
C0289313 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0289313 (UMLS CUI [2,2])
C1882083 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
C0948807 (UMLS CUI [5,1])
C1278039 (UMLS CUI [5,2])
C0201836 (UMLS CUI [5,3])
C0201899 (UMLS CUI [5,4])
C0201850 (UMLS CUI [5,5])
C2347612 (UMLS CUI [5,6])
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