HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

NCT01147848 | Completed Phase 3 Results

• 1 other identifier: 113091
• Study Type: interventional
• Target: 810
• Locations: 6 countries
• Sites: 63

Brief Summary

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Conditions

Asthma

Keywords

Salmeterol; fluticasone furoate; Vilanterol; fluticasone propionate; GW642444

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24

  Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.

  Baseline and Day 168/Week 24

Secondary Outcomes (6)

• Serial FEV1 (0-24 Hours)

  Day 168

• Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1

  Baseline to Day 1

• Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)

  Baseline and Randomization

• Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168

  Baseline and Day 168

• Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1

  Baseline and Day 168

Other Outcomes (6)

• Baseline FEV1 by Completion Status

  Baseline

• Change From Baseline in Asthma Control Test (ACT) Scores at Day 168

  Baseline and Day 168

• Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168

  Baseline to Day 168

Study Arms (2)

Fluticasone furoate/Vilanterol (GW642444)

EXPERIMENTAL

Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks

Drug: Fluticasone furoate/Vilanterol Inhalation Powder; Drug: Placebo (2)

Fluticasone propionate/salmeterol

ACTIVE COMPARATOR

Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks

Drug: Fluticasone propionate/salmeterol Inhalation Powder; Drug: Placebo (1)

Interventions

Fluticasone furoate/Vilanterol Inhalation Powder DRUG

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks

Fluticasone furoate/Vilanterol (GW642444)

Fluticasone propionate/salmeterol Inhalation Powder DRUG

Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks

Fluticasone propionate/salmeterol

Placebo (1) DRUG

Inhalation powder inhaled orally once daily for 24 weeks

Fluticasone propionate/salmeterol

Placebo (2) DRUG

Inhalation powder inhaled orally twice daily for 24 weeks

Fluticasone furoate/Vilanterol (GW642444)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of asthma
• Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
• FEV1 of 40-85% predicted normal
• Currently using inhaled corticosteroid therapy

You may not qualify if:

• History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
• Respiratory infection or oral candidiasis
• Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
• Uncontrolled disease or clinical abnormality
• Allergies
• Taking another investigational medication or prohibited medication
• Night shift workers
• Current smokers or subjects with smoking history of at least 10 pack years

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (63)

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Los Angeles, California, 90025, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

Location

GSK Investigational Site

San Diego, California, 92117, United States

Location

GSK Investigational Site

Centennial, Colorado, 80112, United States

Location

GSK Investigational Site

Denver, Colorado, 80230, United States

Location

GSK Investigational Site

Cocoa, Florida, 32927, United States

Location

GSK Investigational Site

Bethesda, Maryland, 20814, United States

Location

GSK Investigational Site

Wheaton, Maryland, 20902, United States

Location

GSK Investigational Site

Rolla, Missouri, 65401, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Cherry Hill, New Jersey, 08003, United States

Location

GSK Investigational Site

Skillman, New Jersey, 08558, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27607, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Austin, Texas, 78750, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Waco, Texas, 76712, United States

Location

GSK Investigational Site

Buenos Aires, Buenos Aires, 1425, Argentina

Location

GSK Investigational Site

Buenos Aires, Buenos Aires, C1424BSF, Argentina

Location

GSK Investigational Site

Quilmes, Buenos Aires, B1878FNR, Argentina

Location

GSK Investigational Site

Paraná, Entre Ríos Province, E3100BHK, Argentina

Location

GSK Investigational Site

Mendoza, Mendoza Province, M5500CCG, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, S2000DSR, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, S2000JKR, Argentina

Location

GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

Location

GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

Location

GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

Location

GSK Investigational Site

Rancagua, Reg Del Libert Bern Ohiggins, 2841959, Chile

Location

GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Location

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500691, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7601003, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Almelo, 7609 PP, Netherlands

Location

GSK Investigational Site

Breda, 4819 EV, Netherlands

Location

GSK Investigational Site

Dordrecht, 3318 AT, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Harderwijk, 3844 DG, Netherlands

Location

GSK Investigational Site

Heerlen, 6419 PC, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Veldhoven, 5504 DB, Netherlands

Location

GSK Investigational Site

Cabanatuan City, Nueva Ecija, 3100, Philippines

Location

GSK Investigational Site

Cebu City, 6000, Philippines

Location

GSK Investigational Site

Dasmariñas, Cavite, 4114, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Marilao, Bulacan, 3019, Philippines

Location

GSK Investigational Site

Quezon City, 1100, Philippines

Location

GSK Investigational Site

Cheongju, Chungcheongbuk-do, 361-711, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Kangwon-do, 220-701, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

Related Publications (2)

• 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.

  PMID: 36472162 DERIVED

• Woodcock A, Bleecker ER, Lotvall J, O'Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013 Oct;144(4):1222-1229. doi: 10.1378/chest.13-0178.

  PMID: 23846316 DERIVED

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 18, 2017
• Results First Posted: September 5, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (8); US (25); CL (7); AR (10); PH (6); KR (7)