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Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165138
First received: July 15, 2010
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Fluticasone furoate/Vilanterol Inhalation Powder
Drug: Fluticasone Furoate Inhalation Powder
Drug: Placebo Inhaltion Powder
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 in all subjects [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
  • Weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects performing serial FEV1 [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the percentage of rescue-free 24-hour periods [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in the percentage of symptom-free 24-hour periods [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in total AQLQ (+12) score [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
  • Number of withdrawals due to lack of efficacy [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Clinic Visit, 12-hour FEV1 in the subset of subjects performing serial FEV1 assesments [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
  • Weighted mean serial FEV1over 0-24 hours post dose in the subset of subjects performing serial FEV1 assessment [ Time Frame: Over the first day of treatment ] [ Designated as safety issue: No ]
  • Weighted mean serial FEV1over 0-4 hours post dose in the subset of subjects performing serial FEV1 assessment [ Time Frame: During the first day of treatment and at the end of the 12-week treatment period ] [ Designated as safety issue: No ]
  • Time to onset of bronchodilator effect (the timepoint when FEV1 first exceeded 12.0% and 200mL increase over baseline) in the subset of subjects performing serial FEV1 assessments [ Time Frame: Over the first day of treatment ] [ Designated as safety issue: No ]
  • Mean change in daily AM PEF [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Mean change in daily PM PEF [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in Asthma control Test (ACT) [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
  • Global assessment of change (assess asthma symptom change (improve, same, worse) and rescue use (more, same, less) [ Time Frame: At the end of 4 weeks, 8 weeks and the 12-week treatment period ] [ Designated as safety issue: No ]
  • Unscheduled Healthcasre Resource Utilisation for Asthma [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • Inhaler use assessment [ Time Frame: At teh end of 2 weeks and 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Ease of use assessment on the inhaler [ Time Frame: At the end of 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 612
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate/Vilanterol (GW642444)
Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks
 Drug: Fluticasone furoate/Vilanterol Inhalation Powder
Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks
Experimental: Fluticasone Furoate
Fluticasone furoate inhalation powder once daily for 12 weeks
 Drug: Fluticasone Furoate Inhalation Powder
Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks
Placebo Comparator: Placebo
Placebo inhalation powder once daily for 12 weeks
 Drug: Placebo Inhaltion Powder
Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients at least 12 years of age
  • Male and female; female subjects of childbearing potential must be willing to use birth control
  • Pre-bronchodilator FEV1 of 40-90% predicted normal
  • Reversibility FEV1 of at least 12% and 200mL
  • Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit

Exclusion Criteria:

  • History of life-threatening asthma during last 10 years
  • Respiratory infection or oral candidiasis
  • Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
  • Uncontrolled disease or clinical abnormality
  • Allergies to study drugs or the excipients
  • Taking another investigational medication or prohibited medication
  • Night shift workers
  • Current smokers or subjects with a smoking history of at least 10 pack years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165138

  Show 67 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165138     History of Changes
Other Study ID Numbers: 106827
Study First Received: July 15, 2010
Last Updated: May 24, 2012
Health Authority: Russian Federation: Federal service on surveillance in healthcare and social development of Russian Federation
Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Ukraine: The Central Ethics Committee of Ministry of Health of Ukraine
Japan: Pharmaceutical and Medical Device Agency
Romania: National Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW642444
Vilanterol
Asthma
Fluticasone Furoate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013