ID

34921

Description

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains Alcohol intake; urine test for drugs, cotinine and alcohol; history of tobacco use. It has to be filled in for screening.

Keywords

Versions (3)
  1. 2/1/19 2/1/19 -
  2. 2/4/19 2/4/19 -
  3. 2/4/19 2/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

English

Alcohol intake; urine test for drugs, cotinine and alcohol; history of tobacco use

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Alcohol intake
Description

Alcohol intake

Alias
UMLS CUI-1
C0001948
Record the average number of units of alcohol consumed per week
Description

Note: If more than 21 units of alcohol a week (14 units for females) or an average daily intake of greater than 4 units (3 units for females), the subject is not eligible for the study. Alcohol converter: 1 unit of alcohol in UK = half pint of beer (220 ml) or 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

Data type

float

Measurement units
  • units per week
Alias
UMLS CUI [1]
C0560579
units per week
Urine test for drugs, cotinine and alcohol
Description

Urine test for drugs, cotinine and alcohol

Alias
UMLS CUI-1
C0202274
UMLS CUI-2
C0202304
UMLS CUI-3
C1697737
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Substances
Description

Substances

Data type

integer

Alias
UMLS CUI [1]
C0002778
Test result
Description

Note: If any of the above are positive, the subject is not eligible for the study

Data type

text

Alias
UMLS CUI [1]
C0587081
History of tobacco use
Description

History of tobacco use

Alias
UMLS CUI-1
C0841002
What is the subject's history of tobacco use?
Description

Never smoked: Never smoked. Current smoker: Currently smoking or has smoked within 6 months of screening visit. Former smoker: Previously smoked and has not smoked for at least 6 months prior to screening visit. Note: If the subject is not a non-smoker for at least the past 12 months with a pack history~ 5 pack years, the subject is not eligible for the study.

Data type

integer

Alias
UMLS CUI [1]
C0841002
If former smoker, when did the subject last smoke?
Description

da month year

Data type

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0011008
If current or former smoker: Average number of cigarettes smoked per day?
Description

Converter for tobacco products: 1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette

Data type

float

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1]
C3694146
cigarettes per day
If current or former smoker: Number of years during which the subject has smoked?
Description

Smoking years (number)

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
If current or former smoker: Number of pack years?
Description

Calculation for number of pack years: (Average number of cigarettes smoked per day/20) x number of years smoked

Data type

integer

Measurement units
  • pack years
Alias
UMLS CUI [1]
C1277691
pack years
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Similar models

Alcohol intake; urine test for drugs, cotinine and alcohol; history of tobacco use

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Alcohol consumption per week
Item
Record the average number of units of alcohol consumed per week
float
C0560579 (UMLS CUI [1])
Item Group
Urine test for drugs, cotinine and alcohol
C0202274 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C1697737 (UMLS CUI-3)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Item
Substances
integer
C0002778 (UMLS CUI [1])
Substances
Code List
Substances
CL Item
Cannabinoids (1)
CL Item
Amphetamines (2)
CL Item
Benzodiazepines (3)
CL Item
Cocaine (4)
CL Item
Opiates (5)
CL Item
Barbiturates (6)
CL Item
Cotinine (7)
CL Item
Urine Alcohol (8)
Item
Test result
text
C0587081 (UMLS CUI [1])
Test result
Code List
Test result
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
History of tobacco use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of tobacco use?
integer
C0841002 (UMLS CUI [1])
History of tobacco use
Code List
What is the subject's history of tobacco use?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Date of last smoke
Item
If former smoker, when did the subject last smoke?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Average number of cigarettes smoked per day
Item
If current or former smoker: Average number of cigarettes smoked per day?
float
C3694146 (UMLS CUI [1])
Smoking years (number)
Item
If current or former smoker: Number of years during which the subject has smoked?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Pack years
Item
If current or former smoker: Number of pack years?
integer
C1277691 (UMLS CUI [1])
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