Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01436071
First received: September 15, 2011
Last updated: August 22, 2013
Last verified: April 2013
  Purpose

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids


Condition Intervention Phase
Asthma
Drug: Fluticasone furoate 50mcg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Not Currently Receiving Inhaled Corticosteroids

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in trough (pre-bronchodilator and pre-dose) FEV1 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 12 week treatment period. Clinic FEV1 will be measured at screening and at all on-treatment clinic visits.


Secondary Outcome Measures:
  • Change from baseline in the percentage of rescue-free 24 hour periods [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the percentage of rescue-free 24 hour periods during the 12 week treatment period.

  • Change from baseline in daily PM PEF (pre-bronchodilator) [ Time Frame: Averaged over the 12 week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in daily AM PEF (pre-bronchodilator) [ Time Frame: Averaged over the 12 week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in percentage of symptom free 24hr periods [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline symptom-free 24 hour periods during the 12 week treatment period

  • Number of of withdrawals due to lack of efficacy [ Time Frame: Occuring at any time during the 12 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
Drug: Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
Placebo Comparator: Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler
Drug: Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler

Detailed Description:

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent
  • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
  • Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
  • Pre-bronchodilator FEV1 of at least 60% predicted
  • FEV1 reversibility of at least 12% and 200mls
  • Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria:

  • History of life-threatening asthma exacerbation within the past 10 years
  • Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
  • Current or recent respiratory infection or current oral candida infection
  • Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
  • Known or suspected allergy to study drug or materials
  • Taking another investigational medication or prohibited medication during the study
  • Previous treatment with inhaled fluticasone furoate in a phase II or III study
  • Current smokers or former smokers with significant tobacco exposure
  • Children in Care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436071

Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Newport Beach, California, United States, 92663
United States, Georgia
GSK Investigational Site
Albany, Georgia, United States, 31707
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
GSK Investigational Site
Corsicana, Texas, United States, 75110
GSK Investigational Site
Waco, Texas, United States, 76712
Mexico
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45040
GSK Investigational Site
Morelia, Michoacán, Mexico, 58070
GSK Investigational Site
Villahermosa, Tabasco, Mexico, 86100
Peru
GSK Investigational Site
Lima 18, Lima, Peru
GSK Investigational Site
San Borja, Lima, Peru, Lima 41
GSK Investigational Site
San Miguel, Lima, Peru, Lima 32
GSK Investigational Site
Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, Lima 1
Russian Federation
GSK Investigational Site
Klin, Russian Federation, 141600
GSK Investigational Site
Moscow, Russian Federation, 115446
GSK Investigational Site
Saratov, Russian Federation, 410028
GSK Investigational Site
St. Petersburg, Russian Federation, 194356
GSK Investigational Site
Voronezh, Russian Federation, 394066
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01436071     History of Changes
Other Study ID Numbers: 115283
Study First Received: September 15, 2011
Last Updated: August 22, 2013
Health Authority: Peru: Ministry of Health
United States: Food and Drug Administration
Russia: Russian Ministry of Health
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

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

ClinicalTrials.gov processed this record on August 20, 2014