Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; 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: September 5, 2013
Last verified: September 2013
  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 (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.


Condition Intervention Phase
Asthma
Drug: Fluticasone Furoate
Drug: FF/Vilanterol (VI; 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 (FF)/Vilanterol (VI; GW642444M) Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period [ Time Frame: Baseline and Day 29 of each treatment period (up to Study Day 197) ] [ Designated as safety issue: No ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.


Secondary Outcome Measures:
  • Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period [ Time Frame: Baseline and Day 29 of each treatment period (up to Study Day 197) ] [ Designated as safety issue: No ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.

  • Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period [ Time Frame: Baseline and Day 29 of each treatment period (up to Study Day 197) ] [ Designated as safety issue: No ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value

  • Number of Participants With Treatment-emergent Adverse Events (AEs) [ Time Frame: From the start of study medication until Follow-up/Early Withdrawal (up to 197 days) ] [ Designated as safety issue: No ]
    The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.


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
Other Name: Placebo
Active Comparator: inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)
ICS/LABA inhaler
Drug: FF/Vilanterol (VI; GW642444M)
FF/VI
Other Name: FF/VI
Active Comparator: ICS
ICS inhaler
Drug: Fluticasone Furoate
FF
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
Results First Received: June 6, 2013
Last Updated: September 5, 2013
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 April 23, 2014