Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response

NCT01128569 | Completed Phase 2 Results

• 1 other identifier: 113090
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Asthma

Keywords

mild asthma; allergen challenge; early asthmatic response

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline and Day 29 of each treatment period (up to Study Day 197)

Secondary Outcomes (3)

• 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

  Baseline and Day 29 of each treatment period (up to Study Day 197)

• 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

  Baseline and Day 29 of each treatment period (up to Study Day 197)

• Number of Participants With Treatment-emergent Adverse Events (AEs)

  From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Inhaler

Drug: Placebo

inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)

ACTIVE COMPARATOR

ICS/LABA inhaler

Drug: FF/Vilanterol (VI; GW642444M)

ICS

ACTIVE COMPARATOR

ICS inhaler

Drug: Fluticasone Furoate

Interventions

Fluticasone Furoate DRUG

FF

Also known as: FF

ICS

FF/Vilanterol (VI; GW642444M) DRUG

FF/VI

Also known as: FF/VI

inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)

Placebo DRUG

Placebo Inhaler

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

GSK Investigational Site

Wellington, 6021, New Zealand

Location

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (1)

• Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M. Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012 Jun 27;2(1):11. doi: 10.1186/2045-7022-2-11.

  PMID: 22738148 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 18, 2017
• Results First Posted: September 11, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); NZ (1); GB (2)