Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

NCT01134042 | Completed Phase 3 Results

• 1 other identifier: 106829
• Study Type: interventional
• Target: 587
• Locations: 6 countries
• Sites: 71

Brief Summary

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

Conditions

Asthma

Keywords

Fluticasone propionate; asthma; vilanterol; GW642444; Fluticasone furoate

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Clinic Visit Trough (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. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.

  Baseline and Week 24

• Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.

  Baseline and Week 24

Secondary Outcomes (2)

• Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period

  Baseline and Week 24

• Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal

  Baseline, Week 12, and Week 24/Early Withdrawal

Other Outcomes (7)

• Clinic Visit 12-hour Post-dose FEV1at Week 24

  Week 24

• Change From Baseline in Weighted Mean Serial FEV1 Over 0 to 4 Hours Post-dose at Week 24

  Baseline and Week 24

• Mean Change From Baseline in Daily Morning Trough (AM) and Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period

  From Baseline up to Week 12 and Week 24

Study Arms (3)

Fluticasone Furoate/Vilanterol

EXPERIMENTAL

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

Drug: Fluticasone Furoate/Vilanterol Inhalation Powder; Other: Placebo Inhalation Powder 2

Fluticasone Furoate

ACTIVE COMPARATOR

Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks

Drug: Fluticasone Furoate Inhalation Powder; Other: Placebo Inhalation Powder 2

Fluticasone Propionate

ACTIVE COMPARATOR

Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks

Drug: Fluticasone Propionate Inhalation Powder; Other: Placebo Inhalation Powder 1

Interventions

Fluticasone Furoate/Vilanterol Inhalation Powder DRUG

Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks

Fluticasone Furoate/Vilanterol

Fluticasone Furoate Inhalation Powder DRUG

Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks

Fluticasone Furoate

Fluticasone Propionate Inhalation Powder DRUG

Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks

Fluticasone Propionate

Placebo Inhalation Powder 1 OTHER

Placebo in novel dry powder inhaler once daily

Fluticasone Propionate

Placebo Inhalation Powder 2 OTHER

Placebo in Diskus inhaler twice daily

Fluticasone Furoate; Fluticasone Furoate/Vilanterol

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:

• Outpatient at least 12 years of age
• Both genders; females of childbearing potential must be willing to use birth control method
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mls
• Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit

You may not qualify if:

• History of life-threatening asthma
• Respiratory infection or oral candidiasis
• Asthma exacerbation within 12 weeks
• Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
• Allergies to study drugs, study drugs' excipients, medications related to study drugs
• Taking another investigational medication or medication prohibited for use during this study

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (71)

GSK Investigational Site

Bell Gardens, California, 90201, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Long Beach, California, 90808, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

Riverside, California, 92506, United States

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GSK Investigational Site

Roseville, California, 95661, United States

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GSK Investigational Site

San Diego, California, 92128, United States

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GSK Investigational Site

Clearwater, Florida, 33756, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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GSK Investigational Site

Panama City, Florida, 32405, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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GSK Investigational Site

Normal, Illinois, 61761, United States

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GSK Investigational Site

River Forest, Illinois, 60305, United States

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GSK Investigational Site

Asheville, North Carolina, 28801, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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GSK Investigational Site

Lake Oswego, Oregon, 97035, United States

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Medford, Oregon, 97504, United States

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GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

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GSK Investigational Site

Austin, Texas, 78756, United States

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GSK Investigational Site

El Paso, Texas, 79925, United States

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GSK Investigational Site

Sugar Land, Texas, 77479, United States

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GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

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GSK Investigational Site

Schwedt, Brandenburg, 16303, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20354, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

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GSK Investigational Site

Gelnhausen, Hesse, 63571, Germany

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GSK Investigational Site

Kassel, Hesse, 34121, Germany

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GSK Investigational Site

Rüsselsheim am Main, Hesse, 65428, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30167, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

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GSK Investigational Site

Fukuoka, 811-1394, Japan

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GSK Investigational Site

Hiroshima, 732-0052, Japan

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GSK Investigational Site

Hyōgo, 672-8048, Japan

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GSK Investigational Site

Ishikawa, 920-8530, Japan

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GSK Investigational Site

Kagawa, 762-0031, Japan

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GSK Investigational Site

Kyoto, 603-8161, Japan

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GSK Investigational Site

Okayama, 712-8064, Japan

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GSK Investigational Site

Okinawa, 901-2132, Japan

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GSK Investigational Site

Shizuoka, 430-8558, Japan

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GSK Investigational Site

Shizuoka, 438-8550, Japan

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GSK Investigational Site

Tokyo, 105-0003, Japan

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GSK Investigational Site

Tokyo, 158-0083, Japan

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GSK Investigational Site

Bialystok, 15-010, Poland

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GSK Investigational Site

Działdowo, 13-200, Poland

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GSK Investigational Site

Gdansk, 80-169, Poland

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GSK Investigational Site

Gdansk, 84-462, Poland

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GSK Investigational Site

Gliwice, 44-100, Poland

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GSK Investigational Site

Krakow, 31-202, Poland

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GSK Investigational Site

Piekary Śląskie, 41-940, Poland

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GSK Investigational Site

Sopot, 81-741, Poland

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GSK Investigational Site

Bucharest, 020125, Romania

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GSK Investigational Site

Bucharest, 030317, Romania

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GSK Investigational Site

Iași, 700115, Romania

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GSK Investigational Site

Oradea, 410176, Romania

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GSK Investigational Site

Ploieşti, 100550, Romania

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GSK Investigational Site

Suceava, 720284, Romania

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GSK Investigational Site

Timișoara, 300310, Romania

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GSK Investigational Site

Kazan', 420015, Russia

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GSK Investigational Site

Moscow, 115 280, Russia

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GSK Investigational Site

Moscow, 115446, Russia

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GSK Investigational Site

Moscow, 123182, Russia

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GSK Investigational Site

Moscow, 125367, Russia

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GSK Investigational Site

Moscow, 127018, Russia

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GSK Investigational Site

Ryazan, 390026, Russia

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GSK Investigational Site

Saint Petersburg, 198216, Russia

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GSK Investigational Site

Smolensk, 214001, Russia

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GSK Investigational Site

Yaroslavl, Russia

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GSK Investigational Site

Yekaterinburg, 620109, Russia

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Related Publications (4)

• Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563.e1. doi: 10.1016/j.jaip.2020.07.040. Epub 2020 Aug 6. No abstract available.

  PMID: 32771685 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.

  PMID: 27881132 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.

  PMID: 26704701 DERIVED

• O'Byrne PM, Bleecker ER, Bateman ED, Busse WW, Woodcock A, Forth R, Toler WT, Jacques L, Lotvall J. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014 Mar;43(3):773-82. doi: 10.1183/09031936.00064513. Epub 2013 Oct 17.

  PMID: 24136330 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

Condition Hierarchy (Ancestors)

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

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: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 11, 2017
• Results First Posted: August 8, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (10); US (23); PL (8); RO (7); JP (12); RU (11)