Asthma Exacerbation Study | NCT01086384

Label	Type	Description	Intervention Names
Fluticasone furoate/GW642444	Experimental		Drug: Fluticasone Furoate/GW642444
fluticasone furoate	Experimental		Drug: Fluticasone furoate

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone Furoate/GW642444	Drug	Combination inhaled corticosteroid and long-acting beta2-agonist	Fluticasone furoate/GW642444

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With 1 or More Severe Asthma Exacerbations	Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.	Baseline to Follow-up (up to 76 weeks of treatment)

Secondary Outcomes

Measure	Description	Time Frame
Number of Severe Asthma Exacerbations	A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.	Baseline to Follow-up (up to 76 weeks of treatment)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35209	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
27881132	Derived	O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
26704701	Derived	Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
106837	Annotated Case Report Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FP 250 µg/ICS	Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With 1 or More Severe Asthma Exacerbations

Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.

Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.

Posted

Number

participants

Baseline to Follow-up (up to 76 weeks of treatment)

ID	Title	Description
OG000	FF 100 µg	Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
OG001	FF/VI 100/25 µg	Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

Units	Counts
Participants	OG0001010 OG0011009

Title

Denominators

Categories

Title	Measurements
	OG000186 OG001154

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Regression Cox	0.795			2-Sided	95	0.642	0.985			The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.		Superiority or Other
OG000 OG001		Regression, Cox

Secondary

Number of Severe Asthma Exacerbations

A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.

ITT Population

Posted

Number

Severe asthma exacerbations

Baseline to Follow-up (up to 76 weeks of treatment)

ID	Title	Description
OG000	FF 100 µg	Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
OG001	FF/VI 100/25 µg	Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

Units	Counts

Secondary

Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36

Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.

ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.

Posted

Least Squares Mean

Standard Deviation

Liters

Baseline and Week 36

ID	Title	Description
OG000	FF 100 µg	Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
OG001	FF/VI 100/25 µg	Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected1,010 at risk EG00111 affected1,009 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected1,010 at risk EG0014 affected1,009 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Bronchitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Chronic sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Labyrinthitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Meningitis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Subcutaneous abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,009 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Osteochondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Renal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,009 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Tachyarrthmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,009 at risk
Diabetic microangiopathy	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Anal fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Fear	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,009 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Anaphylactic reaction	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,009 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG000131 affected1,010 at risk EG001155 affected1,009 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00093 affected1,010 at risk EG00173 affected1,009 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00074 affected1,010 at risk EG00159 affected1,009 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG00038 affected1,010 at risk EG00150 affected1,009 at risk
Sinusitus	Infections and infestations	MedDRA	Systematic Assessment	EG00038 affected1,010 at risk EG00142 affected1,009 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00041 affected1,010 at risk EG00129 affected1,009 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG000179 affected1,010 at risk EG001188 affected1,009 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00064 affected1,010 at risk EG00155 affected1,009 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00055 affected1,010 at risk EG00141 affected1,009 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00026 affected1,010 at risk EG00139 affected1,009 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00026 affected1,010 at risk EG00133 affected1,009 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00040 affected1,010 at risk EG00141 affected1,009 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00023 affected1,010 at risk EG00136 affected1,009 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	FF 100 µg	Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
BG001	FF/VI 100/25 µg	Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FF 100 µg	Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.			29	1,010	479	1,010
EG001	FF/VI 100/25 µg	Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.			41	1,009	467	1,009