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Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01018186
First received: November 5, 2009
Last updated: November 8, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444


Condition Intervention Phase
Asthma
 Drug: Fluticasone Furoate/GW642444
Drug: Fluticasone propionate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double Dummy, Active Comparator, Parallel Group, Multicenter Study to Evaluate the Safety of Once-Daily Fluticasone Furoate/GW642444 Inhalation Powder for 52 Weeks in Adolescent and Adult Subjects With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events, asthma exacerbations, laboratory, urine cortisol, oropharyngeal, vital signs, ECGs, Holters, ophthalmic assessments [ Time Frame: Over the 1 year treatment period ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate/GW642444 Drug: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
Active Comparator: Fluticasone propionate Drug: Fluticasone propionate
Inhaled corticosteroid

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of asthma
  • Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
  • FEV1 greater than or equal to fifty percent of predicted
  • Currently using moderate to high dose inhaled corticosteroid therapy

Exclusion Criteria:

  • History of life threatening asthma
  • Respiratory infection or oral candidiasis
  • Asthma exacerbation
  • Uncontrolled disease or clinical abnormality
  • Allergies
  • Taking another investigational medication or prohibited medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018186

  Show 38 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01018186     History of Changes
Other Study ID Numbers: 106839
Study First Received: November 5, 2009
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

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 June 17, 2013