NCT01244984

Brief Summary

The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 9, 2013

Completed
Last Updated

January 11, 2017

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

November 18, 2010

Results QC Date

June 6, 2013

Last Update Submit

November 23, 2016

Conditions

Asthma

Keywords

asthmaFluticasone furoateGW642444

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAE.

    From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Secondary Outcomes (22)

  • Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

    Baseline (Week -2), Week 12, Week 24, and Week 52/WD

  • Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

    Baseline (Week -2), Week 12, Week 24, and Week 52/WD

  • Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD

    Baseline (Week -2), Week 12, Week 24, and Week 52/WD

  • Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

    Baseline (Week -2), Week 12, Week 24, and Week 52/WD

  • Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

    Baseline (Week -2), Week 12, Week 24, and Week 52/WD

  • +17 more secondary outcomes

Study Arms (2)

Fluticasone Furoate/GW642444

EXPERIMENTAL

Combination inhaled corticosteroid and long-acting beta2-agonist

Drug: Fluticasone Furoate/GW642444 Inhalation Powder

Fluticasone Furoate

EXPERIMENTAL

Inhaled corticosteroid

Drug: Fluticasone Furoate Inhalation Powder

Interventions

Fluticasone Furoate/GW642444 Inhalation PowderDRUG

Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Fluticasone Furoate/GW642444
Fluticasone Furoate Inhalation PowderDRUG

Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks

Fluticasone Furoate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out patient at least 18 years of age
  • Both genderds; females of childbearing potential must be willing to use birth control method
  • A diagnosis of asthma at least 6 months prior to Screening
  • A best FEV1 of at least 50% of the predicted nomal value at Screening
  • Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening

You may not qualify if:

  • History of life-threating asthma
  • Respiratory infection or oral candidiasis
  • Asthma exacerbation within 12 weeks
  • Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
  • Allergies to study drugs, study drugs7 excipients, medications related to study drugs
  • Taking another investigational medication or medication prohibited for use during this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

GSK Investigational Site

Chiba, 277-0863, Japan

Location

GSK Investigational Site

Fukuoka, 802-0083, Japan

Location

GSK Investigational Site

Fukuoka, 816-0813, Japan

Location

GSK Investigational Site

Gifu, 501-6062, Japan

Location

GSK Investigational Site

Gunma, 373-0021, Japan

Location

GSK Investigational Site

Hiroshima, 730-0844, Japan

Location

GSK Investigational Site

Hiroshima, 732-0062, Japan

Location

GSK Investigational Site

Hiroshima, 739-0402, Japan

Location

GSK Investigational Site

Hyōgo, 665-0827, Japan

Location

GSK Investigational Site

Hyōgo, 670-0046, Japan

Location

GSK Investigational Site

Hyōgo, 672-8064, Japan

Location

GSK Investigational Site

Ibaraki, 302-0022, Japan

Location

GSK Investigational Site

Kanagawa, 231-8682, Japan

Location

GSK Investigational Site

Kanagawa, 253-0041, Japan

Location

GSK Investigational Site

Kyoto, 601-1495, Japan

Location

GSK Investigational Site

Kyoto, 615-8087, Japan

Location

GSK Investigational Site

Miyagi, 983-0824, Japan

Location

GSK Investigational Site

Miyagi, 983-8520, Japan

Location

GSK Investigational Site

Nagano, 390-0303, Japan

Location

GSK Investigational Site

Nagano, 390-8510, Japan

Location

GSK Investigational Site

Okayama, 700-0862, Japan

Location

GSK Investigational Site

Okayama, 701-0304, Japan

Location

GSK Investigational Site

Okayama, 714-0081, Japan

Location

GSK Investigational Site

Osaka, 545-8586, Japan

Location

GSK Investigational Site

Osaka, 569-1192, Japan

Location

GSK Investigational Site

Osaka, 589-0022, Japan

Location

GSK Investigational Site

Tokyo, 105-0004, Japan

Location

GSK Investigational Site

Tokyo, 134-0083, Japan

Location

GSK Investigational Site

Tokyo, 185-0014, Japan

Location

GSK Investigational Site

Toyama, 937-0066, Japan

Location

Related Publications (2)

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PMID: 36472162DERIVED

  • O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

    PMID: 27881132DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune 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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 22, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 11, 2017

Results First Posted

August 9, 2013

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Individual Participant Data Set (113989)Access
Annotated Case Report Form (113989)Access
Clinical Study Report (113989)Access
Dataset Specification (113989)Access
Informed Consent Form (113989)Access
Statistical Analysis Plan (113989)Access
Study Protocol (113989)Access

Locations

JP(30)