Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents

NCT01431950 | Completed Phase 3 Results

• 1 other identifier: 114496
• Study Type: interventional
• Target: 238
• Locations: 6 countries
• Sites: 40

Brief Summary

A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

Conditions

Asthma

Keywords

fluticasone furoate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.

  Baseline and Week 24

Secondary Outcomes (4)

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

  From Baseline up to Week 24

• Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period

  From Baseline up to Week 24

• Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period

  From Baseline up to Week 24

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

  From Baseline up to Week 24

Study Arms (2)

FF 100mcg once daily

EXPERIMENTAL

Inhaled corticosteroid (ICS)

Drug: fluticasone furoate; Drug: albuterol/salbutamol

FF 200mcg once daily

EXPERIMENTAL

Inhaled corticosteroid

Drug: fluticasone furoate; Drug: albuterol/salbutamol

Interventions

fluticasone furoate DRUG

Inhaled corticosteroid

FF 100mcg once daily; FF 200mcg once daily

albuterol/salbutamol DRUG

Provided as rescue relief of asthma symptoms

FF 100mcg once daily; FF 200mcg once daily

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit
• Both genders; females of child bearing potential must be willing to use appropriate contraception
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mLs
• Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit

You may not qualify if:

• History of life threatening asthma
• Respiratory infection or candidiasis
• Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
• Concurrent respiratory disease or other disease that would confound study participation of affect subject safety
• Allergies to study drugs, study drug excipients, medications related to study drugs
• Taking another investigational medication or medication prohibited for use during the study
• Previous treatment with FF or FF/VI in a phase II or III study
• Night shift workers
• Children in care

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (40)

GSK Investigational Site

Long Beach, California, 90808, United States

Location

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

Albany, Georgia, 31707, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40503, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Bethesda, Maryland, 20814, United States

Location

GSK Investigational Site

Plymouth, Minnesota, 55441, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89119, United States

Location

GSK Investigational Site

Brick, New Jersey, 08724, United States

Location

GSK Investigational Site

Utica, New York, 13502, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45242, United States

Location

GSK Investigational Site

Toledo, Ohio, 43617, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

GSK Investigational Site

Corsicana, Texas, 75110, United States

Location

GSK Investigational Site

Mendoza, Mendoza Province, M5500CCG, Argentina

Location

GSK Investigational Site

Buenos Aires, C1121ABE, 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

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500800, Chile

Location

GSK Investigational Site

Aigrefeuille-sur-Maine, 44140, France

Location

GSK Investigational Site

Bourg-des-Comptes, 35890, France

Location

GSK Investigational Site

Châlons-en-Champagne, 51000, France

Location

GSK Investigational Site

Laon, 02000, France

Location

GSK Investigational Site

Nantes, 44300, France

Location

GSK Investigational Site

Vannes, 56000, France

Location

GSK Investigational Site

Villahermosa, Tabasco, 86100, Mexico

Location

GSK Investigational Site

Mexico City, 07760, Mexico

Location

GSK Investigational Site

Belgorod, 308007, Russia

Location

GSK Investigational Site

Kazan', 420015, Russia

Location

GSK Investigational Site

Novokuznetsk, 654063, Russia

Location

GSK Investigational Site

Penza, 440067, Russia

Location

GSK Investigational Site

Pyatigorsk, 357538, Russia

Location

Related Publications (4)

• 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.

  PMID: 27881132 DERIVED

• Woodcock A, Lotvall J, Busse WW, Bateman ED, Stone S, Ellsworth A, Jacques L. Efficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014 Jul 9;14:113. doi: 10.1186/1471-2466-14-113.

  PMID: 25007865 DERIVED

• Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.

  PMID: 24966061 DERIVED

• Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

  PMID: 24314123 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; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 12, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 9, 2017
• Results First Posted: September 3, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

AR (5); FR (6); ME (2); US (19); RU (5); CL (3)