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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01436110
First received: September 15, 2011
Last updated: August 15, 2013
Last verified: April 2013
  Purpose

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids


Condition Intervention Phase
Asthma
Drug: Fluticasone furoate 50mcg
Drug: Fluticasone propionate 100mcg
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, Double-dummy, Placebo Controlled Multi-centre Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder and Fluticasone Propionate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents Not Currently Treated With Inhaled Corticosteroids

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in clinic visit (pre-dose, pre bronchodilator) FEV1 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 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 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period

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

  • Number of Withdrawals due to Lack of Efficacy [ Time Frame: During the 24 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate 50 mcg
Once daily inhalation powder via Novel Dry Powder Inhaler
Drug: Fluticasone furoate 50mcg
Once daily inhalation powder via Novel Dry Powder Inhaler
Active Comparator: Fluticasone propionate 100mcg
Twice daily inhalation powder via DISKUS/ ACCUHALER
Drug: Fluticasone propionate 100mcg
Twice daily inhalation powder via DISKUS/ACCUHALER
Placebo Comparator: Placebo
Inhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER
Drug: Placebo
Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER

Detailed Description:

This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, 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 scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 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 a 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 during the study
  • Pre-bronchodilator FEV1 of at least 60% predicted
  • FEV1 reversibility of at least 12% and 200ml
  • Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist

Exclusion Criteria:

  • History of life-threatening asthma exacerbation with the past 10 years
  • Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
  • Current or recent respiratory infection or current oral candida infection
  • Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
  • Known or suspected allergy to study medication or materials
  • Taking another investigational medication or prohibited medication during the study
  • Current smokers or former smokers with significant tobacco exposure
  • Previous treatment with fluticasone furoate in a phase II or III study
  • Children in Care
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436110

  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01436110     History of Changes
Other Study ID Numbers: 115285
Study First Received: September 15, 2011
Last Updated: August 15, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Peru: Ministry of Health
Netherlands: Centrale Commissie Mensgebonden Onderzoek
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
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 April 16, 2014