ID

32396

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)
  1. 10/30/18 10/30/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

October 30, 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

English

Eligibility Form

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Form
Eligibility Question
Description

Eligibility Question

Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

If NO, please select all boxes corresponding to violations of any inclusion/exclusion criteria:
Description

If NO, please select all boxes corresponding to violations of any inclusion/exclusion criteria:

Data type

text

Has any criteria been violated?
Description

Mark below

Data type

text

Inclusion Criteria
Description

Inclusion Criteria

Type of Subject: Outpatient
Description

Type of Subject: Outpatient

Data type

boolean

Age
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

Gender
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

Asthma Diagnosis
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

Severity of Disease
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

Reversibility of disease
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

Current Anti-Asthma Therapy
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

Asthma Exacerbation History
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

Short-Acting Beta2 -Agonists
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

text

Informed Consent
Description

All subjects must be able and willing to give written informed consent to take part in the study.

Data type

boolean

Dosage Lists
Description

Dosage Lists

List 1 ICS Dosage List for ICS Use Without Concurrent LABA
Description

Asthma Therapy (Toltal Daily Dose (mcg/day)) 1=Ex-actuator dose 2=Ex-valve dose 3=Ex-mouth piece

Data type

integer

List 2 Combination Dosage List
Description

Asthma Therapy (Total Daily Dose (mcg/day))

Data type

integer

Exclusion Criteria
Description

Exclusion Criteria

History of Life-Threatening Asthma
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

Concurrent Respiratory Disease
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

Other concurrent Diseases/Abnormalities
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

Oral Candidiasis
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

Investigational Medications
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

Previous Participation
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

Drug Allergy
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

Milk Protein Allergy
Description

History of severe milk protein allergy.

Data type

boolean

Immunosuppressive medications
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

Attendance
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

Neurological or psychiatric disease or history of drug or alcohol use
Description

it could interfere with the subjects proper completion of the protocol requirements.

Data type

boolean

Concomitant Medications
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

Tobacco Use
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

Affiliation with Investigators Site
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

Cytochrome P450 3A4 (CYP 3A4) Inhibitors
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

The List of Additional Excluded Conditions/Diseases
Description

it includes but is not limited to the following:

Data type

text

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Similar models

Eligibility Form

1 forms
  1. StudyEvent: ODM
    1. Eligibility Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Question
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If NO, please select all boxes corresponding to violations of any inclusion/exclusion criteria:
Item
If NO, please select all boxes corresponding to violations of any inclusion/exclusion criteria:
text
Has any criteria been violated?
Item
Has any criteria been violated?
text
Item Group
Inclusion Criteria
Type of Subject: Outpatient
Item
Type of Subject: Outpatient
boolean
Age
Item
Age
boolean
Gender
Item
Gender
boolean
Asthma Diagnosis
Item
Asthma Diagnosis
boolean
Severity of Disease
Item
Severity of Disease
boolean
Reversibility of disease
Item
Reversibility of disease
boolean
Current Anti-Asthma Therapy
Item
Current Anti-Asthma Therapy
boolean
Asthma Exacerbation History
Item
Asthma Exacerbation History
boolean
Short-Acting Beta2 -Agonists
Item
Short-Acting Beta2 -Agonists
text
Informed Consent
Item
Informed Consent
boolean
Item Group
Dosage Lists
Item
List 1 ICS Dosage List for ICS Use Without Concurrent LABA
integer
List 1 ICS Dosage List for ICS Use Without Concurrent LABA
Code List
List 1 ICS Dosage List for ICS Use Without Concurrent LABA
CL Item
Fluticasone propionate MDI CFC/HFA (176 to 880-1 (200 to 1000-2)) (1)
CL Item
Fluticasone propionate DPI (200 to 1000) (2)
CL Item
Beclomethasone dipropionate CFC (420 to 1680-1 (500 to 2000-2)) (3)
CL Item
Beclomethasone dipropionate HFA (QVAR) (160 to 640-1 (200 to 800-2)) (4)
CL Item
Budesonide DPI/MDI (360 to 2000) (5)
CL Item
Flunisolide (500 to 2000) (6)
CL Item
Triamcinolone acetonide (400 to 2000) (7)
CL Item
Mometasone furoate (200 to 800-3) (8)
CL Item
Ciclesonide MDI HFA (160 to 640-1 (200 to 800-2)) (9)
CL Item
In addition, subjects may be using a combination product with an ICS (as per specific prescribing information) or an ICS plus a LABA for at least 12 weeks before preceding Visit 1 and at a stable dose for at least 4 weeks preceding Visit 1. The LABA in the combination product must be stopped at Visit 1 while maintaining the stable dose of the ICS through the run-in period. See List 1 for examples of allowed doses of commonly used combination medications. (10)
Item
List 2 Combination Dosage List
integer
List 2 Combination Dosage List
Code List
List 2 Combination Dosage List
CL Item
Fluticasone propionate/salmeterol (200/100 to 500/100) (1)
CL Item
Budesonide/formoterol fumarate (320/18 to 640/18) (2)
CL Item
Beclomethasone dipropionate/formoterol (200/12 to 400/24) (3)
Item Group
Exclusion Criteria
History of Life-Threatening Asthma
Item
History of Life-Threatening Asthma
boolean
Concurrent Respiratory Disease
Item
Concurrent Respiratory Disease
boolean
Other concurrent Diseases/Abnormalities
Item
Other concurrent Diseases/Abnormalities
boolean
Oral Candidiasis
Item
Oral Candidiasis
boolean
Investigational Medications
Item
Investigational Medications
boolean
Previous Participation
Item
Previous Participation
boolean
Drug Allergy
Item
Drug Allergy
boolean
Milk Protein Allergy
Item
Milk Protein Allergy
boolean
Immunosuppressive medications
Item
Immunosuppressive medications
boolean
Attendance
Item
Attendance
boolean
Neurological or psychiatric disease or history of drug or alcohol use
Item
Neurological or psychiatric disease or history of drug or alcohol use
boolean
Concomitant Medications
Item
Concomitant Medications
boolean
Tobacco Use
Item
Tobacco Use
boolean
Affiliation with Investigators Site
Item
Affiliation with Investigators Site
integer
Cytochrome P450 3A4 (CYP 3A4) Inhibitors
Item
Cytochrome P450 3A4 (CYP 3A4) Inhibitors
boolean
Item
The List of Additional Excluded Conditions/Diseases
text
The List of Additional Excluded Conditions/Diseases
Code List
The List of Additional Excluded Conditions/Diseases
CL Item
Congestive heart failure (1)
CL Item
Clinically significant cardiac arrhythmia (2)
CL Item
Clinically significant coronary heart disease (3)
CL Item
Uncontrolled hypertension (4)
CL Item
Stroke within 3 month of Visit 1 (5)
CL Item
Hematologic, hepatic or renal disease (6)
CL Item
Recent or poorly controlled peptic ulcer (7)
CL Item
Current malignancy (8)
CL Item
Immunologic compromise (9)
CL Item
Cushing disease (10)
CL Item
Tuberculosis (current or untreated) (11)
CL Item
Uncontolled diabetes mellitus (12)
CL Item
Addison's disease (13)
CL Item
Recent history of drug or alcohol abuse (14)
CL Item
known aortic aneurysm (15)
CL Item
Uncontrolled thyroid disorder (16)
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