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Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fluticasone furoate/Vilanterol Inhalation Powder

Fluticasone Furoate Inhalation Powder

Placebo Inhaltion Powder

About this trial

This is an interventional treatment trial for Asthma focused on measuring GW642444, Vilanterol, Asthma, Fluticasone Furoate

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatients at least 12 years of age
Male and female; female subjects of childbearing potential must be willing to use birth control
Pre-bronchodilator FEV1 of 40-90% predicted normal
Reversibility FEV1 of at least 12% and 200mL
Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit

Exclusion Criteria:

History of life-threatening asthma during last 10 years
Respiratory infection or oral candidiasis
Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
Uncontrolled disease or clinical abnormality
Allergies to study drugs or the excipients
Taking another investigational medication or prohibited medication
Night shift workers
Current smokers or subjects with a smoking history of at least 10 pack years

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluticasone furoate/Vilanterol (GW642444)

Fluticasone Furoate

Placebo

Arm Description

Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks

Fluticasone furoate inhalation powder once daily for 12 weeks

Placebo inhalation powder once daily for 12 weeks

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m

Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.

Secondary Outcome Measures

Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period

The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.

Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period

Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.

Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal

The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline.

Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period

The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

Serial FEV1 Over 0-1 Hour Post-dose at Randomization

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.

Full Information

NCT ID

NCT01165138

First Posted

July 15, 2010

Last Updated

January 18, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01165138

Brief Title

Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Official Title

HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

August 20, 2010 (undefined)

Primary Completion Date

October 1, 2011 (Actual)

Study Completion Date

October 19, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

GW642444, Vilanterol, Asthma, Fluticasone Furoate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

612 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluticasone furoate/Vilanterol (GW642444)

Arm Type

Experimental

Arm Description

Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks

Arm Title

Fluticasone Furoate

Arm Type

Experimental

Arm Description

Fluticasone furoate inhalation powder once daily for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo inhalation powder once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Fluticasone furoate/Vilanterol Inhalation Powder

Intervention Description

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Fluticasone Furoate Inhalation Powder

Intervention Description

Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo Inhaltion Powder

Intervention Description

Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal

Description

Time Frame

Baseline and Week 12/Early Withdrawal

Title

Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period

Description

The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

Time Frame

From the first dose of the study medication up to Week 12/Early Withdrawal

Title

Serial FEV1 Over 0-1 Hour Post-dose at Randomization

Description

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.

Time Frame

Randomization

Other Pre-specified Outcome Measures:

Title

Clinic Visit 12-hour Post-dose FEV1 at Week 12

Description

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.

Time Frame

Week 12

Title

Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline

Description

Time Frame

Baseline

Title

Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12

Description

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.

Time Frame

Baseline and Week 12

Title

Number of Participants With Bronchodilator Effect

Description

Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).

Time Frame

Baseline

Title

Mean Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

Description

Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.

Time Frame

From Baseline up to Week 12

Title

Mean Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

Description

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.

Time Frame

From Baseline up to Week 12

Title

Change From Baseline in the Asthma Control Test (ACT) Score at Week 12

Description

The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, "How much of the time did your asthma keep you from getting as much done at work, school or at home?", "How often have you had shortness of breath?", "How often did your asthma symptoms wake you up at night or earlier than usual in the morning?", "How often have you used your rescue inhaler or nebulizer medication (such as albuterol)?" and "How would you rate your asthma control"? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline.

Time Frame

Baseline and Week 12/Early Withdrawal

Title

Number of Participants With the Indicated Global Assessment of Change Responses at Week 4, Week 8, and Week 12/Early Withdrawal

Description

At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).

Time Frame

Week 4, Week 8, and Week 12/Early Withdrawal

Title

Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period

Description

All unscheduled asthma-related visits to a physician's office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.

Time Frame

From Baseline up to Week 12/Early Withdrawal

Title

Number of Participants Who Used the Inhaler Correctly or Incorrectly at Baseline, Week 2, and Week 4

Description

Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.

Time Frame

Baseline (BL), Week 2 (W2), and Week 4 (W4)

Title

Number of Participants With the Indicated Reason for Incorrect Inhaler Use and Who Required Additional Instruction the Indicated Number of Times at Baseline, Week 2, and Week 4

Description

Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again. and the number of times that the participants required additional instruction (RAI) was recorded.

Time Frame

Baseline, Week 2, and Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients at least 12 years of age Male and female; female subjects of childbearing potential must be willing to use birth control Pre-bronchodilator FEV1 of 40-90% predicted normal Reversibility FEV1 of at least 12% and 200mL Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit Exclusion Criteria: History of life-threatening asthma during last 10 years Respiratory infection or oral candidiasis Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment Uncontrolled disease or clinical abnormality Allergies to study drugs or the excipients Taking another investigational medication or prohibited medication Night shift workers Current smokers or subjects with a smoking history of at least 10 pack years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

GSK Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

GSK Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

GSK Investigational Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

GSK Investigational Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

GSK Investigational Site

City

Rolla

State/Province

Missouri

ZIP/Postal Code

65401

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

GSK Investigational Site

City

Lake Oswego

State/Province

Oregon

ZIP/Postal Code

97035

Country

United States

Facility Name

GSK Investigational Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

GSK Investigational Site

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

GSK Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68161

Country

Germany

Facility Name

GSK Investigational Site

City

Oranienburg

State/Province

Brandenburg

ZIP/Postal Code

16515

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

GSK Investigational Site

City

Gelnhausen

State/Province

Hessen

ZIP/Postal Code

63571

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12165

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14057

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

732-0052

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

064-0801

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

672-8048

Country

Japan

Facility Name

GSK Investigational Site

City

Ishikawa

ZIP/Postal Code

920-8530

Country

Japan

Facility Name

GSK Investigational Site

City

Kagawa

ZIP/Postal Code

762-0031

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

252-0143

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

603-8161

Country

Japan

Facility Name

GSK Investigational Site

City

Okinawa

ZIP/Postal Code

901-2132

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

158-0083

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

194-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

GSK Investigational Site

City

Tczew

ZIP/Postal Code

83-110

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

53-301

Country

Poland

Facility Name

GSK Investigational Site

City

Zawadzkie

ZIP/Postal Code

47-120

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

020674

Country

Romania

Facility Name

GSK Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

GSK Investigational Site

City

Craiova

ZIP/Postal Code

200642

Country

Romania

Facility Name

GSK Investigational Site

City

Deva

ZIP/Postal Code

330084

Country

Romania

Facility Name

GSK Investigational Site

City

Pitesti

ZIP/Postal Code

110084

Country

Romania

Facility Name

GSK Investigational Site

City

Ploiesti

ZIP/Postal Code

100550

Country

Romania

Facility Name

GSK Investigational Site

City

Suceava

ZIP/Postal Code

720284

Country

Romania

Facility Name

GSK Investigational Site

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49006

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49051

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kiev

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

02660

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03038

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04201

Country

Ukraine

Facility Name

GSK Investigational Site

City

Simferopol

ZIP/Postal Code

95043

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhia

ZIP/Postal Code

69076

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

27881132

Citation

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.

Results Reference

derived

PubMed Identifier

26704701

Citation

Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

Results Reference

derived

PubMed Identifier

25213048

Citation

Bleecker ER, Lotvall J, O'Byrne PM, Woodcock A, Busse WW, Kerwin EM, Forth R, Medley HV, Nunn C, Jacques L, Bateman ED. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61. doi: 10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.

Results Reference

derived

PubMed Identifier

24966061

Citation

Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.

Results Reference

derived

PubMed Identifier

24314123

Citation

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Results Reference

derived

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106827

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106827

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106827

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106827

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106827

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106827

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106827

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Learn more about this trial

Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

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Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Asthma

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