DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fluticasone Furoate/ Vilanterol 200/25 mcg (Drug); Fluticasone Furoate/ Vilanterol 100/25 mcg (Drug); Fluticasone Furoate 100 mcg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).

Clinical Details

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period

Secondary outcome:

Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period

Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period

Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period

Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must give their signed and dated (written) informed consent to participate.

Written informed consent must be obtained if a subject's current medication is changed as a result of study participation

- Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as

defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age

- Male or an eligible female. Eligible female is defined as having non-childbearing

potential or having childbearing potential and using an acceptable method of birth control consistently and correctly.

- Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value.

- Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes

following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required.

- If subject have received ICS for at least 12 weeks prior to Visit 1 and their

treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e. g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e. g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers.

- Use of ICS/LABA are not permitted with LABA on the day of Visit 1.

- Must be able to replace current SABA treatment with albuterol/salbutamol aerosol

inhaler at Visit 1 for use as needed, during 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 as an asthma episode that required

intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.

- 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 that required oral corticosteroids within the 12 weeks prior

to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.

- A subject must not have current evidence of atelectasis (segmental or larger),

bronchopulmonary dysplasia, chronic obstructive pulmonary 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 efficacy results if the condition/disease exacerbated during the study

- Chronic stable hepatitis B or C are acceptable provided their screening alanine

transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible

- Clinical visual evidence of candidiasis at Visit 1

- Use of any investigational drug within 30 days prior to Visit 1 or within five

half-lives (t½), whichever is longer of the two.

- Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist,

sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy

- Administration of medication that would significantly affect the course of asthma, or

interact with study drug

- Use of immunosuppressive medications during the study.

- Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1.

- A subject or his/her parent or legal guardian has any infirmity, disability, disease,

or resides in a 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 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 within the past 3 months (i. e., cigarettes, cigars, or pipe tobacco).

- If subject is an immediate family member of the participating investigator,

sub-investigator, study coordinator, or employee of the participating investigator.

- Subject previously randomized to treatment with FF/VI or FF in another Phase III

study

- Subjects working on night shift a week prior to Visit 1 or during the study period.

- Adolescents who are wards of the state or government

Locations and Contacts

GSK Investigational Site, Berazategui 1886, Argentina

GSK Investigational Site, Buenos Aires C1425BEN, Argentina

GSK Investigational Site, Buenos Aires C1425FVH, Argentina

GSK Investigational Site, Buenos Aires C1424BSF, Argentina

GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1426ABP, Argentina

GSK Investigational Site, Mendoza 5500, Argentina

GSK Investigational Site, Mendoza M5500CCG, Argentina

GSK Investigational Site, San Miguel de Tucumán 4000, Argentina

GSK Investigational Site, Tucuman 4000, Argentina

GSK Investigational Site, Santiago 8380453, Chile

GSK Investigational Site, Berlin 14050, Germany

GSK Investigational Site, Berlin 10787, Germany

GSK Investigational Site, Berlin 12203, Germany

GSK Investigational Site, Berlin 13086, Germany

GSK Investigational Site, Berlin 10717, Germany

GSK Investigational Site, Almelo 7609 PP, Netherlands

GSK Investigational Site, Breda 4819 EV, Netherlands

GSK Investigational Site, Eindhoven 5623 EJ, Netherlands

GSK Investigational Site, Enschede 7513 ER, Netherlands

GSK Investigational Site, Hoorn 1624 NP, Netherlands

GSK Investigational Site, Veldhoven 5504 DB, Netherlands

GSK Investigational Site, Zutphen 7207 AE, Netherlands

GSK Investigational Site, Bialystok 15-027, Poland

GSK Investigational Site, Krakow 31-455, Poland

GSK Investigational Site, Krakow 31-024, Poland

GSK Investigational Site, Krakow 30-901, Poland

GSK Investigational Site, Lodz 90-242, Poland

GSK Investigational Site, Tarnow 33-100, Poland

GSK Investigational Site, Warszawa 02-507, Poland

GSK Investigational Site, Wroclaw 53-301, Poland

GSK Investigational Site, Bacau 600114, Romania

GSK Investigational Site, Brasov 500112, Romania

GSK Investigational Site, Bucharest 020125, Romania

GSK Investigational Site, Bucharest 030317, Romania

GSK Investigational Site, Bucuresti 022102, Romania

GSK Investigational Site, Cluj Napoca 400370, Romania

GSK Investigational Site, Craiova 200642, Romania

GSK Investigational Site, Deva 330084, Romania

GSK Investigational Site, Iasi 700115, Romania

GSK Investigational Site, Pitesti 110084, Romania

GSK Investigational Site, Ploiesti 100172, Romania

GSK Investigational Site, Ploiesti 100184, Romania

GSK Investigational Site, Timisoara 300310, Romania

GSK Investigational Site, Blagoveshchensk 675000, Russian Federation

GSK Investigational Site, Chelyabinsk 454021, Russian Federation

GSK Investigational Site, Chita 672090, Russian Federation

GSK Investigational Site, Ekaterinburg 620109, Russian Federation

GSK Investigational Site, Ivanovo 153005, Russian Federation

GSK Investigational Site, Kazan 420015, Russian Federation

GSK Investigational Site, Moscow 115446, Russian Federation

GSK Investigational Site, Moscow 123182, Russian Federation

GSK Investigational Site, Moscow 123367, Russian Federation

GSK Investigational Site, Nizhniy Novgorod 603126, Russian Federation

GSK Investigational Site, Pyatigorsk 357538, Russian Federation

GSK Investigational Site, Ryazan 390039, Russian Federation

GSK Investigational Site, St. Petersburg 194291, Russian Federation

GSK Investigational Site, St. Petersburg 194356, Russian Federation

GSK Investigational Site, St. Petersburg 197022, Russian Federation

GSK Investigational Site, Stavropol 355030, Russian Federation

GSK Investigational Site, Tomsk 634 050, Russian Federation

GSK Investigational Site, Vladivostok 690950, Russian Federation

GSK Investigational Site, Voronezh 394066, Russian Federation

GSK Investigational Site, Göteborg SE-413 90, Sweden

GSK Investigational Site, Linköping SE-582 16, Sweden

GSK Investigational Site, Luleå SE-971 89, Sweden

GSK Investigational Site, Lund SE-221 85, Sweden

GSK Investigational Site, Uppsala SE-751 85, Sweden

GSK Investigational Site, Dnipropetrovsk 49051, Ukraine

GSK Investigational Site, Kharkiv 61124, Ukraine

GSK Investigational Site, Kharkiv 61002, Ukraine

GSK Investigational Site, Kiev 03680, Ukraine

GSK Investigational Site, Kyiv 04201, Ukraine

GSK Investigational Site, Kyiv 03680, Ukraine

GSK Investigational Site, Poltava 36024, Ukraine

GSK Investigational Site, Vinnytsia 21018, Ukraine

GSK Investigational Site, Vinnytsia 21029, Ukraine

GSK Investigational Site, Zaporizhia 69035, Ukraine

GSK Investigational Site, Zaporizhia 69063, Ukraine

GSK Investigational Site, Zaporizhia 69076, Ukraine

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Potsdam, Brandenburg 14467, Germany

GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires C1405BCH, Argentina

GSK Investigational Site, Nueve de Julio, Buenos Aires B6500BWQ, Argentina

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Los Angeles, California 90025, United States

GSK Investigational Site, Newport Beach, California 92663, United States

GSK Investigational Site, Rancho Mirage, California 92270, United States

GSK Investigational Site, Rolling Hills Estates, California 90274, United States

GSK Investigational Site, San Diego, California 92103-8415, United States

GSK Investigational Site, Vista, California 92083, United States

GSK Investigational Site, Colorado Springs, Colorado 80907, United States

GSK Investigational Site, Denver, Colorado 80206, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Frankfurt, Hessen 60389, Germany

GSK Investigational Site, Frankfurt, Hessen 60596, Germany

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States

GSK Investigational Site, Normal, Illinois 61761, United States

GSK Investigational Site, Zapopan, Jalisco 45040, Mexico

GSK Investigational Site, Bethesda, Maryland 20814, United States

GSK Investigational Site, Columbia, Maryland 21044, United States

GSK Investigational Site, North Dartmouth, Massachusetts 02747, United States

GSK Investigational Site, San Rafael, Mendoza 5600, Argentina

GSK Investigational Site, Morelia, Michoacán 58070, Mexico

GSK Investigational Site, Minneapolis, Minnesota 55402, United States

GSK Investigational Site, Rolla, Missouri 65401, United States

GSK Investigational Site, St. Louis, Missouri 63143, United States

GSK Investigational Site, Skillman, New Jersey 08558, United States

GSK Investigational Site, Charlotte, North Carolina 28207, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Shelby, North Carolina 28152, United States

GSK Investigational Site, Monterrey, Nuevo León 64000, Mexico

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Cincinnati, Ohio 45242, United States

GSK Investigational Site, Middleburg Heights, Ohio 44130, United States

GSK Investigational Site, Medford, Oregon 97504, United States

GSK Investigational Site, Rancagua, Reg Del Libert Bern Ohiggins 2841959, Chile

GSK Investigational Site, Puente Alto - Santiago, Región Metro De Santiago 8207257, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago 7500800, Chile

GSK Investigational Site, Koblenz, Rheinland-Pfalz 56068, Germany

GSK Investigational Site, Leipzg, Sachsen 04109, Germany

GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany

GSK Investigational Site, Rosario, Santa Fe S2000JKR, Argentina

GSK Investigational Site, Grosshansdorf, Schleswig-Holstein 22927, Germany

GSK Investigational Site, Easley, South Carolina 29640, United States

GSK Investigational Site, Fort Mill, South Carolina 29707, United States

GSK Investigational Site, Greenville, South Carolina 29615, United States

GSK Investigational Site, Orangeburg, South Carolina 29118, United States

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Villahermosa, Tabasco 86100, Mexico

GSK Investigational Site, El Paso, Texas 79903, United States

GSK Investigational Site, Waco, Texas 76712, United States

GSK Investigational Site, Quillota, Valparaíso 2260000, Chile

GSK Investigational Site, Valparaiso, Valparaíso 2341131, Chile

GSK Investigational Site, Viña del Mar, Valparaíso, Chile

GSK Investigational Site, Richmond, Virginia 23219, United States

GSK Investigational Site, Seattle, Washington 98122, United States

Additional Information

Starting date: September 2012
Last updated: July 10, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017