Information:
Error:
ID
32656
Description
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma
Keywords
Versions (2)
- 11/9/18 11/9/18 -
- 11/9/18 11/9/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 9, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138
Date of visit/ assessment, Subject Identification, Demography, Eligibility Question, Screen Failure, Investigator Signature, Previous Clinical Trial Participation - Screening
Similar models
Date of visit/ assessment, Subject Identification, Demography, Eligibility Question, Screen Failure, Investigator Signature, Previous Clinical Trial Participation - Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-3)
C2985720 (UMLS CUI-3)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C1830427 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of birth - Imputed
Item
Date of birth - Imputed
date
C0421451 (UMLS CUI [1,1])
C2825504 (UMLS CUI [1,2])
C2825504 (UMLS CUI [1,2])
CL Item
Male (M)
CL Item
Female: Record child- bearing potential (F)
Item
If subject is female, record child- bearing potential
integer
C3831118 (UMLS CUI [1])
CL Item
Pre- menopausal (1)
CL Item
Post- menopausal (2)
CL Item
Sterile (of child- bearing age) (3)
CL Item
Potentially able to bear children (4)
Date of final menses
Item
If subject is post- menopausal, record date of final menses
date
C0425932 (UMLS CUI [1])
Date became sterile
Item
If subject is sterile (of child- bearing age), record date became sterile
date
C0021359 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/ African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/ South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/ North African Heritage (18)
CL Item
White - White/ Caucasian/ European Heritage (19)
Subject Status
Item
Subject Status
text
C2348568 (UMLS CUI [1])
Item
Did the subject meet all the entry criteria? - Inclusion Criteria
integer
C1516637 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
Code List
Did the subject meet all the entry criteria? - Inclusion Criteria
CL Item
Informed consent: Subjects must give their signed and dated written informed consent to participate (1)
CL Item
Type of Subject: Outpatients 12 years of age or older at Visit 1. For sites in the following countries subjects will be >= 18 years of age: Germany, Poland, and other countries where local regulations or the regulatory status of study medication permit enrolment of adults only. Subjects must have a diagnosis of asthma as defined by the National Institutes of Health (NIH, 2007) at least 12 weeks prior to Visit 1. (2)
CL Item
Gender: Male or Eligible Female, defined as non- childbearing potential or childbearing potential using an acceptable method of birth control consistently and correctly, as defined by the following: (3)
CL Item
- Male partner who is sterile prior to the female subjects entry into the study and is the sole sexual partner for that female subject (4)
CL Item
- Implants of levonorgestrel, etonogetsrel (5)
CL Item
- Injectable progesteron (6)
CL Item
- Oral contraceptive (either combined oestrogen/ progestin or progestin only) (7)
CL Item
- Any intrauterine device (IUD) with a documented failure rate of less than 1% per year (8)
CL Item
- Double barrier method - spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm). (9)
CL Item
- Oestrogenic vaginal ring (10)
CL Item
- Percutaneous contraceptive patches (11)
CL Item
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days) (12)
CL Item
- Female subjects should not be enrolled if they are pregnant, lactating, or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial screening vsit (Visit 1) and Visit 7 or Early Withdrawal. In addition a urine pregancy test will be performed on all females of childbearing potential at randomisation (Visit 3) and Follow- up Visit (Visit 8). (13)
CL Item
Severity of Disease: A best pre- bronchodilator FEV, of 40% - 90% of the predicted nromal value at the Visit 1 screening visit. Predicted values will be based upo NHANES III (Hankinson, 1999). If a subject is recorded as having Hispanic or Latino ethnicity, then the Mexian- American equations will be used (irrespective of race). If a subject is recorded as being of African- American/ African heritage race, then the African- American equation will be used. If a subject is recorded as being of Asian race, then the Asian adjustment will be used (Hankinson, 2010). Otherwise, the Caucasian equations will be used. (4)
CL Item
Reversibility of Disease: Demonstrated >= 12% and >= 200mL reversibility of FEV1 within 10 - 40 minutes following 2 - 4 inhalations of albuterol/ salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/ salbutamol solution) at the Screening Visit (5)
CL Item
Current Anti- Asthma Therapy: All subjects must be using an ICS with or without LABA for at least 12 weeks prior ti Visit 1. (6)
CL Item
Two populations are eligible for enrolment: (17)
CL Item
Subjects maintained on a stable ICS dose (FP 100 - 250mcg twice daily or equivalent) for at least 4 weeks prior to Visit 1. (18)
CL Item
OR (19)
CL Item
Subjects must be maintained on a stable dose of an ICS/ LABA low- dose combination product (e. g., Seretide/ Advair 100/ 50 twice daily or equivalent via other combination products or via separate inhalers) for at least 4 weeks prior to Visit 1. Subjects taking Symbicort as needed must switch to Symbicort maintenance dosing with use of a short acting beta2 agonist (SABA) for symptom relief at least 4 weeks prior to Visit 1. (20)
CL Item
LABA therapy is not permitted beginning on the day of Visit 1 (last dose of LABA to be taken on day prior to Visit 1). Combination therapy must be stopped at Visit 1 and subjects switched to the same ICS dose of the same ICS for the run- in- period. (21)
CL Item
Short- Acting Beta2- Agonists (SABA): All subjects must be able to replace their current SABA treatment with albuterol/ salbutamol aerosol inhaler at Visit1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/ salbutamol for at least 6 hours prior to study visits. (7)
Item
Did the subject meet all the entry criteria? - Exclusion Criteria
integer
C1516637 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
CL Item
History of Life- threatening asthma: Defined for this protocol as an asthma episode that required intubation and/ or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years (1)
CL Item
Respiratory Infection: Culture- documented ar suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subjects asthma status or the subjects ability to participate in the study. (2)
CL Item
Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. (3)
CL Item
Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnomalities other than asthma. (4)
CL Item
Other Concurrent Diseases (5)
CL Item
Abnormalities: (6)
CL Item
A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator,m would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/ disease exacerbated during the study. (7)
CL Item
Oropharygeal Examination: A subject will not be eligible for the run- in if the he/ she has clinical visual evidence of canididas at Visit 1. (6)
CL Item
Investigational Medications: A subject must not have used any Investigational drug within 30 days prior to Visit1 or within five half- lives (t1/2) of the prior investigational study (which ever is longer of the two) (7)
CL Item
Allergies: (8)
CL Item
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2- agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constitutes of the Novel DPI (i.e. lactose or magnesium stearate). (11)
CL Item
- Milk Protein Allergy: History of severe milk protein allergy. (12)
CL Item
Concomitant Medication: Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with study drug, such as: anticonvulsivants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta- adrenergic blocking agents; phenothiazines and monoamine oxidase (MAO) inhibitors. (9)
CL Item
- Immunosuppressive Medications: A subject must not be using or require use of immunosuppressive medications during the study. (Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and subjects remain in the maintenance phase for the duration of the study.) (14)
CL Item
- Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a potent CYP3A4 inhibitor within 4 weeks of Visit (e.g., ritronavir, ketoconazole, itraconzole). (15)
CL Item
Compliance: A subject will not be eligibile if he/ she or his/ her parent or legal guardian has any infirmity, disabilitxý, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries. (10)
CL Item
Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 20 cigarettes/ day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco). (11)
CL Item
Affiliation with Investigators Site: A subject will not be eligible for this study if he/ she is an immediate family member of the participating Investigator, sub Investigator, study coordinator, or employee of the participating Investigator. (12)
CL Item
Previous Participation: A subject may not have previously been randomized to treatment in another Phase III fluticasone furoate/ GW642444 combination product study (i.e. HZA106829, HZA106837, HZA106839, HZA106851, HZA113091). (13)
CL Item
Night shift workers: No subject is permitted to perform night shift work for 1 week prior to Visit 1 until completion of the study treatment period. (14)
Screen failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Screen failure date
Item
If subject was screen failure, enter screen failure date.
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
If subject was screen failure, record reason.
integer
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Did not meet inclusion/exc|usion criteria (1)
CL Item
Adverse Event (unspecified) (2)
CL Item
Study clcsed/ terminated (unspecified) (6)
CL Item
Investigator discretion, specify (8)
CL Item
Withdrew consent, specify (9)
If reason for screen failure is Investigator discretion, specify
Item
If reason for screen failure is Investigator discretion, specify.
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
If reason for screen failure is withdrawn consent, specify
Item
If reason for screen failure is withdrawn consent, specify.
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0566251 (UMLS CUI [1,2])
C1707492 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
CL Item
Yes (Y)
Item
Tick or untick this box to require the investigator to sign the case book.
integer
C2346576 (UMLS CUI [1])
Code List
Tick or untick this box to require the investigator to sign the case book.
CL Item
Sign (1)
Item Group
Previous Clinical Trial Participation
C2348568 (UMLS CUI-1)
Previous Fluticasone Furoate and/or GW642444 clinical trial
Item
Did the subject participate in a previous Fluticasone Furoate and/or GW642444 clinical trial?
boolean
C2348568 (UMLS CUI [1,1])
C1948374 (UMLS CUI [1,2])
C1948374 (UMLS CUI [1,2])
Item
If the subject did participate in a previous Fluticasone Furoate and/or GW642444 clinical trial, complete the following
text
C2348568 (UMLS CUI [1,1])
C1948374 (UMLS CUI [1,2])
C1948374 (UMLS CUI [1,2])
Code List
If the subject did participate in a previous Fluticasone Furoate and/or GW642444 clinical trial, complete the following
CL Item
FFA10007 - Subject ([FFA10007])
CL Item
FFA10022 - Subject ([FFA10022])
CL Item
FFA10026 - Subject ([FFA10026])
CL Item
FFA10027 - Subject ([FFA100Z7])
CL Item
FFA10028 - Subject ([FFA10028])
CL Item
FFA106783 - Subject ([FFA106783])
CL Item
FFA109684 - Subject ([FFA109684])
CL Item
FFA109685 - Subject ([FFA109685])
CL Item
FFA109687 - Subject ([FFA109687])
CL Item
FFA112202 - Subject ([FFA112202])
CL Item
FFA20001 - Subject ([FFA20001])
CL Item
HZA108799 - Subject ([HZA108799])
CL Item
B2C101762 - Subject ([B2C101762])
CL Item
B2C104604 - Subject ([B2C104604])
CL Item
B2C106093 - Subject ([B2C106093])
CL Item
B2C106996 - Subject ([B2C106996])
CL Item
B2C109575 - Subject ([B2C109575])
CL Item
HZA113310 - Subject ([HZA113310])
CL Item
FFA114060 - Subject ([FFA114060])
CL Item
FFA112059 - Subject ([FFA112059])