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An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

NCT ID: NCT02301975

Last Updated: 2018-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2016-11-25

Brief Summary

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This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone Furoate/Vilanterol 100/25 mcg

FF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks.

Group Type EXPERIMENTAL

Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler

Intervention Type DRUG

FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.

Placebo inhalation powder via ACCUHALER/DISKUS inhaler

Intervention Type DRUG

Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.

Fluticasone Propionate/Salmeterol 250/50 mcg

FP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Group Type EXPERIMENTAL

Placebo inhalation powders via ELLIPTA inhaler

Intervention Type DRUG

Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler

Intervention Type DRUG

FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.

Fluticasone Propionate 250 mcg

FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Group Type EXPERIMENTAL

Placebo inhalation powders via ELLIPTA inhaler

Intervention Type DRUG

Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

Intervention Type DRUG

FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Interventions

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Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler

FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.

Intervention Type DRUG

Placebo inhalation powders via ELLIPTA inhaler

Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

Intervention Type DRUG

Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler

FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.

Intervention Type DRUG

Placebo inhalation powder via ACCUHALER/DISKUS inhaler

Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.

Intervention Type DRUG

Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities.
* Subjects must be outpatients \>=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects \>=18 years of age only).
* Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly.
* Subjects must have a FEV1 of \>=80% of the predicted normal value.
* Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.
* All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 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.

Exclusion Criteria

* History of Life-Threatening Asthma, 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.
* Culture-documented or 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, expected to affect the subject's asthma status or the subject's ability to participate in the study.
* Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
* A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma
* 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.
* A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two.
* 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 constituents of RELVAR™ ELLIPTA inhaler, SERETIDE™ ACCUHALER/DISKUS inhaler or FP 250.
* History of severe milk protein allergy.
* Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug.
* A subject must not be using or require the use of immunosuppressive medications during the study.
* A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, 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.
* Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco).
* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntington Beach, California, United States

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Riverside, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Albany, Georgia, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Columbia, Missouri, United States

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Rolla, Missouri, United States

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Bellevue, Nebraska, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Hendersonville, North Carolina, United States

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Huntersville, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Middleburg Heights, Ohio, United States

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Medford, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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Lewisville, Texas, United States

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Waco, Texas, United States

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Richmond, Virginia, United States

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Greenfield, Wisconsin, United States

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Florida, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mar del Plata, , Argentina

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Mendoza, , Argentina

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Mendoza, , Argentina

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San Miguel de Tucumán, , Argentina

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Salvador, Estado de Bahia, Brazil

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Goiânia, Goiás, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Valparaíso, Región de Valparaíso, Chile

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Concepción, Región Del Biobio, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, , Chile

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Viña del Mar, , Chile

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Česká Lípa, , Czechia

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Hlučín, , Czechia

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Hradec Králové, , Czechia

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Kutná Hora, , Czechia

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Lovosice, , Czechia

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Olomouc, , Czechia

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Ostrava - Poruba, , Czechia

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Rokycany, , Czechia

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Tábor, , Czechia

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Teplice, , Czechia

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Varnsdorf, , Czechia

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Stuttgart, Baden-Wurttemberg, Germany

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Bamberg, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Potsdam, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Marburg, Hesse, Germany

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Neu-Isenburg, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Peine, Lower Saxony, Germany

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Essen, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Warendorf, North Rhine-Westphalia, Germany

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Witten, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Delitzsch, Saxony, Germany

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Leipzg, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Teuchern, Saxony-Anhalt, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Schleswig, Schleswig-Holstein, Germany

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Schmölln, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Zapopan, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Morelia, Michoacán, Mexico

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Monterrey NL, Nuevo León, Mexico

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Villahermosa, Tabasco, Mexico

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Mexico City, , Mexico

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Almelo, , Netherlands

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Almere Stad, , Netherlands

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Almere Stad, , Netherlands

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Breda, , Netherlands

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Breda, , Netherlands

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Eindhoven, , Netherlands

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Harderwijk, , Netherlands

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Hoorn, , Netherlands

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Kloosterhaar, , Netherlands

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Nijverdal, , Netherlands

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Zutphen, , Netherlands

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Bacau, , Romania

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Bacau, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Codlea, , Romania

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Craiova, , Romania

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Deva, , Romania

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Piteşti, , Romania

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Suceava, , Romania

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Timișoara, , Romania

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Barnaul, , Russia

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Blagoveshchensk, , Russia

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Irkutsk, , Russia

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Kemerovo, , Russia

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Kemerovo, , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Pyatigorsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petesburg, , Russia

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Saratov, , Russia

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St'Petersburg, , Russia

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Stavropol, , Russia

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Tomsk, , Russia

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Tomsk, , Russia

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Ufa, , Russia

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Ulyanovsk, , Russia

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Vladimir, , Russia

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Volgodonsk, , Russia

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Voronezh, , Russia

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Cheongju-si, Chungcheongbuk-do, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon-si, Gyeonggi-do, , South Korea

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Alicante, , Spain

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Alzira/Valencia, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Centelles (Barcelona), , Spain

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Madrid, , Spain

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Pozuelo de Alarcón/Madrid, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Countries

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United States Argentina Brazil Chile Czechia Germany Mexico Netherlands Romania Russia South Korea Spain

References

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Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

Reference Type DERIVED
PMID: 36472162 (View on PubMed)

Bernstein D, Andersen L, Forth R, Jacques L, Yates L. Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA. J Asthma. 2018 Sep;55(9):984-993. doi: 10.1080/02770903.2017.1386214. Epub 2018 Apr 13.

Reference Type DERIVED
PMID: 28961020 (View on PubMed)

Other Identifiers

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201378

Identifier Type: -

Identifier Source: org_study_id

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Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study
NCT01453023 COMPLETED PHASE2
Treatment Of Symptomatic Asthma In Children
NCT00197106 COMPLETED PHASE4
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
NCT02980133 COMPLETED PHASE3
A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma
NCT02680561 COMPLETED PHASE1
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids
NCT01479621 COMPLETED PHASE2
A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma
NCT00452699 COMPLETED PHASE4
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
NCT00393991 COMPLETED PHASE3
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
NCT00394199 COMPLETED PHASE3
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
NCT01128569 COMPLETED PHASE2
Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
NCT00424008 COMPLETED PHASE3