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Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination and FF on an Allergen Induced Asthmatic Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128569
First received: May 20, 2010
Last updated: May 17, 2012
Last verified: March 2012
History of Changes
  Purpose

We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product on protection from allergic triggers in asthma.


Condition Intervention Phase
Asthma
 Drug: Fluticasone Furoate
Drug: FF/GW642444M
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Three-way Crossover, Repeat Dose Pilot Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Weighted mean change from baseline in FEV1 between 0-2 hours, following the 22-23 hour post treatment allergen challenge on Day 29. [ Time Frame: 217 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Max % decrease from baseline in FEV1 0-2hr post challenge D29 [ Time Frame: 217 days ] [ Designated as safety issue: No ]
  • Min FEV1 change from baseline 0-2hr post challange on D29 [ Time Frame: 217 days ] [ Designated as safety issue: No ]
  • Incident of AEs [ Time Frame: 217 days ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Inhaler
 Drug: Placebo
Placebo Inhaler
Active Comparator: ICS/LABA Drug: FF/GW642444M
Active Comparator: ICS Drug: Fluticasone Furoate
Other Name: FF

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
  • Females of non-child bearing potential.
  • Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
  • Pre-bronchodilator FEV1 >70% of predicted at screening
  • Subjects who are current non-smokers
  • Methacholine challenge PC20 < 8 mg/mL at screening
  • Screening allergen challenge demonstrates that the subject experiences an early asthmatic response

Exclusion Criteria:

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  • Subject is hypertensive at screening
  • Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
  • History of life-threatening asthma
  • Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
  • Unable to abstain from short acting beta agonists
  • Unable to abstain from antihistamines
  • Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
  • The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
  • undergoing allergen desensitisation therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128569

Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6021
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01128569     History of Changes
Other Study ID Numbers: 113090
Study First Received: May 20, 2010
Last Updated: May 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
New Zealand: Wellington Ethics Committee
New Zealand: Medicines and Medical Devices Safety Authority
Germany: Berlin Ethics Committee
United Kingdom: NRES Head Office, National Patient Safety Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
mild asthma
allergen challenge
early asthmatic response

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