ID
33087
Description
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
Keywords
Versions (2)
- 10/30/18 10/30/18 -
- 11/26/18 11/26/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 26, 2018
DOI
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License
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Eligibility Form
- StudyEvent: ODM
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Type of Subject: Outpatient
Data type
boolean
Alias
- UMLS CUI [1]
- C0029921
Description
12 years of age or older at Visit 1 (or 18 years of age or older if local regulations or regulatory status of study medication permit enrollment of adults only).
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Male or eligible female. To be eligible for entry into the study, females or childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: -Male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject -Implants of levonorgestrel or etonogestrel -Injectable progestogen -Oral contraceptive (either combined estrogen/progestin or progestin only) -Any intrauterine device (IUD) with a documented failure rate of less that 1% per year -Estrogenic vaginal ring -Double barrier method - spermacide + a mechanical barrier (e.g., a male condom or a female diaphragm) -Percutaneous contraceptive patches -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) -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 visit (Visit 1), Visit 5, Visit 7, Visit 10 and Visit13/Early Withdrawal. A urine pregnancy test will be performed at Visits 2 through 4, Visit 8 through 9, Visits 11 through 12 and the follow-up contact.
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
Description
A diagnosis of asthma as defined by the NAtional Institutes of Health [NIH, 2007] at least 1 year prior to Visit 1.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004096
- UMLS CUI [1,2]
- C0011900
Description
A best FEV1 of 50% to 90% of the predicted normal value at Visit 1. NHANES III predicted values wil be used for subjects≥ 12 years of age [Hankinson, 1999]. If a subject is recorded as having Hispanic or Latino ethnicity, then Mexican-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 equations will be used. If a subject is recorded as being of Asian heritage race, then the Asian equations will be used. Otherwise the Caucasian equations will be used.
Data type
boolean
Alias
- UMLS CUI [1]
- C0521117
Description
Demonstrated a ≥ 12% and ≥ 200 mL reversibility of FEV1 within 10 to 40 minutes following 2 to 4 inhalations of albuterol/salbitamol ihnalation aerosol (if required, spacers are permitted for reversibility testing only) or equivalent nebulized treatment with albuterol/salbutamol solution at screening.
Data type
boolean
Alias
- UMLS CUI [1]
- C0679253
Description
Subjects must be using an approved dose of an ICS (as per specific prescribed information) for at least 12 weeks preceding Visit 1 and at a stable dose for at least 4 weeks preceding Visit 1. See List 1 for examples of allowed doses of commonly used ICS.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0004096
Description
All subjects must have a history of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization for the treatment of asthma within the previous 12 month. NOTE: subjects who have experienced an asthma exacerbation requiring oral/systemic corticosteroids in the 4 weeks prior to Visit 1 can not be enrolled in the study due to 4 week washout of the oral/systemic corticosteroids, but can enter Visit 1 once the washout period has been met.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0349790
- UMLS CUI [1,2]
- C0262926
Description
All subjects must be able to replace short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold all ihaled short-acting beta-sympathomimetic bronchodilators for at least 6 hours prior to study visits.
Data type
boolean
Alias
- UMLS CUI [1]
- C1373132
Description
All subjects must be able and willing to give written informed consent to take part in the study.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Dosage Lists
Description
Asthma Therapy (Toltal Daily Dose (mcg/day)) 1=Ex-actuator dose 2=Ex-valve dose 3=Ex-mouth piece
Data type
integer
Alias
- UMLS CUI [1,1]
- C3248292
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [2,1]
- C1373132
- UMLS CUI [2,2]
- C0178602
Description
Asthma Therapy (Total Daily Dose (mcg/day))
Data type
integer
Alias
- UMLS CUI [1]
- C0178602
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004096
- UMLS CUI [1,2]
- C2826244
Description
A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or respiratory abnormalities other than asthma.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035204
- UMLS CUI [1,2]
- C0205420
Description
A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0205420
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0205420
Description
A subject will not be elligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1.
Data type
boolean
Alias
- UMLS CUI [1]
- C0006849
Description
A subject must not have participated in a study (including a non-interventional study) or used any investigational drug (including devices) within 30 days prior to Vitis 1 or within ten half-lives (t1/2) of the prior investigational study (whichever is longer of the two).
Data type
boolean
Alias
- UMLS CUI [1]
- C0304229
Description
Asubject may not have previously been randomized to treatment in a Phase III Fluticasone Furoate/GW642422 Inhalation Powder Study (i.e., HZA106825, HZA106827, HZA106829, HZA106839,HZA106851).
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic cortocisteroid therapy. Known or suspected sensitivity to the constituents of the Novel Dry Powder Inhaler (i.e., lactose or magnesium stearate).
Data type
boolean
Alias
- UMLS CUI [1]
- C0013182
Description
History of severe milk protein allergy.
Data type
boolean
Alias
- UMLS CUI [1]
- C3889086
Description
A subject must not be using or require use of immunosuppressive medications during the study. NOTE: Immunitherapy 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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021081
Description
A subject will not be elligible if he/she or his/her parent or legal guardian has any infirmity, disability or geographical location which seems likely (in the opinion of the investigator) to impair complianca with any aspect of this study protocol or scheduled visits to the study center and non-compliance with study medication or procedures (i.e., completion of diary card).
Data type
boolean
Alias
- UMLS CUI [1]
- C2827364
Description
it could interfere with the subjects proper completion of the protocol requirements.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027765
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [2,1]
- C0001948
- UMLS CUI [2,2]
- C0281875
Description
Administration of any other prescription or over the counter medication which would significantly affect the course of asthma, or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbymazepine), polycyclic antidepressants, beta-adrenergic blocking agents (both cardio-selective and non-selective), phenothiasines, monoamines oxidase (MOA) inhibitors. Please refer to the SPM for further details.
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
A subject may not have used inhaled tobacco products within the past three month (i.e., cigarettes, cigars or pipe tobacco) or have historical use of 10 pack years or more (e.g., 20 cigarettes/day for 10 years).
Data type
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
A subject will not be eligible if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1510825
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0205145
Description
A subject is not eligible if he/she is receiving a strong CYP 3A4 inhibitor within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole,itraconazole).
Data type
boolean
Alias
- UMLS CUI [1]
- C2962753
Description
it includes but is not limited to the following:
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0332196
Similar models
Eligibility Form
- StudyEvent: ODM
C1709750 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0680251 (UMLS CUI [2,3])
C0011900 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C1373132 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C2826244 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205420 (UMLS CUI [2,3])
C0004936 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0281875 (UMLS CUI [2,2])
C0008961 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,2])