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ID
29545
Beschreibung
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Screening
Stichworte
Versionen (2)
- 10.03.18 10.03.18 -
- 05.04.18 05.04.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. April 2018
DOI
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Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849
Ähnliche Modelle
Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
Item
If Female: Record child-bearing potential
integer
C1960468 (UMLS CUI [1])
CL Item
Post-menopausal (1)
CL Item
sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry
integer
C3841890 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian, Central/South Asian Heritage (3)
CL Item
Asian, East Asian Heritage (4)
CL Item
Aslan, Japanese Heritage (5)
CL Item
Asian, South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White, Arabic/North African Heritage (8)
CL Item
White, White/Caucasian/European Heritage (9)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
integer
C1512693 (UMLS CUI [1])
Code List
Inclusion Criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
CL Item
AST, ALT, alkaline phosphatase and billrubin <= 1.SxULN (isolated billrubln > 1.SxULN Is acceptable if bilirubin is fractionated and direct billrubin <35%). (1)
CL Item
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. (2)
CL Item
Male or female between 18 and 65 years of age Inclusive, at the time of signing the Informed consent. (3)
CL Item
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradlol < 40 pg/ml (<140 pmol/L) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8. 1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit. (4)
CL Item
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose. (5)
CL Item
Body mass index (BMI) within the range 18.5·29.0 kg/m2(inclusive). (6)
CL Item
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose. (5)
CL Item
Body mass index (BMI) within the range 18.5·29.0 kg/m2(inclusive). (6)
CL Item
Capable of giving written Informed consent, which Includes compliance with the requirements and restrictions listed in the consent form (7)
CL Item
Average QTcF < 450 msec. (8)
CL Item
No clinically significant abnormality on the Holter ECG at screening. The criteria for Holter ECG at screening are stated in Appendix 3. (9)
CL Item
Subjects who are current non·smokers, who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of < = 5 pack years. Number of pack years= (number of cigarettes per day/20) x number of years smoked (10)
CL Item
Able to satisfactorily use the dry powder inhaler. (11)
CL Item
10As a result of medical interview, physical examination or screening investigations, the principal invest igator or delegate physician deems the subject unsuitable for the study. Subj ects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg. (1)
CL Item
The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters( >= 85% predicted). (2)
CL Item
Subjects who have suffered a lower respiratory tract Infection within 4 weeks of the screening visit. (3)
CL Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (4)
CL Item
The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric Illness. (5)
CL Item
A positive test lo, HIV antibody. (6)
CL Item
A positive pre-study Hepatitis 6 surface antigen or positive Hepatitis C antibody result within 3 months of screening (7)
CL Item
History of heavy regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (240 ml) of beer, 1 glass (125 ml) of wine or l (25 m l) measure of spirits. (8)
CL Item
History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening . (9)
CL Item
Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit. (10)
CL Item
A positive pre-study urine drug screen or when randomly tested during the study. (11)
CL Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigationa l product (whichever is longer). (12)
CL Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day. (13)
CL Item
Use of prescription or non -prescription drugs, including vitamins, herbal and dietary supplements (includ ing St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half· llves (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. (14)
CL Item
The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit . (15)
CL Item
The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit . (16)
CL Item
History of sensitivity or adverse reaction to any or the study medications including immediate or delayed hypersensitivity to any betaagonist, sympathomlmetic drug, or any intranasal, Inhaled or systemic corticosteroid therapy; known or suspected sensitivity to the constituents of the new powder inhaler (i.e. lactose or magnesium stearate), or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation. (17)
CL Item
History or severe milk protein allergy. (18)
CL Item
Where participation in the study wou ld result in donation of blood or blood prod ucts in excess of 500 ml within 3 months of the start of the study. (19)
CL Item
Pregnant females as determined by positive serum hCG test at screen ing or by positive serum or urine hCG test prior to dosing. (20)
CL Item
Lactating females. (21)
CL Item
Unwillingness or inability to follow the procedures outlined in the protocol. (22)
CL Item
Subject is mentally or legally incapacitated. (23)
CL Item
Consumption or red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication. (24)
Subject Identification
Item
Subject Identification
text
C2348585 (UMLS CUI [1])
Item
Number of measurement
integer
C0518766 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Number of measurement
integer
C0430456 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QTcF Interval
Item
QTcF Interval
float
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
QTcB (Bazett)
Item
QTcB (Bazett)
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form If the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item
Number of measurement
integer
C0748133 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
FEV1
Item
FEV1
float
C0748133 (UMLS CUI [1])
Start Date Holter ECG
Item
Start Date Holter ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time Holter ECG
Item
Start Time Holter ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Stop Date Holter ECG
Item
Stop Date Holter ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Stop Time Holter ECG
Item
Stop Time Holter ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter ECG
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
C0438154 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (3)
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology sample taken
Item
Haematology sample taken?
boolean
C1277698 (UMLS CUI [1])
Date Haematology sample taken
Item
Date Haematology sample taken
date
C1277698 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry Sample taken
Item
Clinical Chemistry Sample taken?
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Clinical Chemistry Sample same as the Haematology sample
Item
Clinical Chemistry Sample same as the Haematology sample?
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urinalysis done
Item
Urinalysis done?
boolean
C0042014 (UMLS CUI [1])
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
randomised
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])