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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01128595

Asthma

COMPLETED PHASE2

An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma

NCT01706198

Asthma

COMPLETED PHASE3

HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

NCT01147848

Asthma

COMPLETED PHASE3

The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma

NCT03363191

Asthma

WITHDRAWN PHASE4

Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

NCT01134042

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo Inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Inhaler

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

ICS/LABA inhaler

Group Type ACTIVE_COMPARATOR

FF/Vilanterol (VI; GW642444M)

Intervention Type DRUG

FF/VI

ICS

ICS inhaler

Group Type ACTIVE_COMPARATOR

Fluticasone Furoate

Intervention Type DRUG

FF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluticasone Furoate

FF

Intervention Type DRUG

FF/Vilanterol (VI; GW642444M)

FF/VI

Intervention Type DRUG

Placebo

Placebo Inhaler

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FF FF/VI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Wellington, , New Zealand

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany New Zealand United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 22738148 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.