Pulmonary Disease, Chronic ObstructivePhase 3NCT01072149

A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo

A Phase 3 study testing Fluticasone Furoate (FF)/GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Fluticasone Furoate (FF)/GW642444 Inhalation Powder
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 8 sitesUnited States
Study dates: 1 Jan 2010to 1 Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient/Inpatient; Male or female subjects
Subjects must give their signed and dated written informed consent to participate.
A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic, > 45 years, in the absence of hormone replacement therapy. However in questionable cases, a blood sample with FSH >40MIU/ml and estradiol < 40pg/ml (<140 pmol/L) is confirmatory.
OR
Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
Complete abstinence from intercourse from screening until the follow-up contact; or

Show all 22Show fewer

Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
Injectable progestogen administered for at least 1 month prior to study medication administration; or
Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
Estrogenic vaginal ring; or
Percutaneous contraceptive patches.
Age: ≥40 years of age at Screening (Visit 1).
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
Tobacco use: subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1).
Note: Pipe and/or cigar use cannot be used to calculate pack year history. Number of pack years = (number of cigarettes per day/20)) x number of years smoked
Severity of Disease:
Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1). [Pelligrino, 2005]
Subjects with a measured post-albuterol/salbutamol FEV1 ≤ 70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e. total 400mcg.) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated by the centralized spirometry equipment.
Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC, 0-4 scale) at Screening (Visit 1).

Who cannot join

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) thats reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening if a chest X-ray or CT scan is not available within 6 months prior to Screening (Visit 1)

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Hospitalization: Subjects who are hospitilized due to poorly controlled COPD with 12 weeks of Screening (Visit 1)
Poorly controlled COPD: Subjects with poorly controlled COPD defined as the occurrence of any of the following in the 6 weeks prior to Screening (Visit 1):
acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics, or that requires treatment prescribed by a physician
Lower respiratory tract infection: Subjects with lower respiratory tract infection that require the use of antibiotics within 6 weeks prior to Screening (Visit 1)
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
Hypertension: Subjects with clinically significant hypertension that is uncontrolled
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. ≤12 hours per day) is not exclusionary.
Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
Prior use of study medication/other investigational drugs: Subjects who have previously been randomized in the Phase IIa (HZC111348 or B2C111045) study or Phase III (i.e. HZC112206, HZC112207, HZC102970, HZC102871) studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer
Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Orlando, Florida, 32822
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Union, South Carolina, 29379

Other trials in United States

About this study

Official title: A Three-way Incomplete Block Crossover Study to Investigate the 24-hour Pulmonary Function of Three Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder vs. Placebo, in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy, plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF) and GW642444 at the end of each treatment period.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Fluticasone Furoate (FF)/GW642444 Inhalation Powder, placebo
Keywords: COPD, Safety, FEV1, Efficacy
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone Furoate (FF)/GW642444 Inhalation PowderDrug
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
placeboDevice
placebo

Study groups in NCT01072149
Study group	Role	What they receive
50mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) Receives: Drug: Fluticasone Furoate (FF)/GW642444 Inhalation Powder
100mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) Receives: Drug: Fluticasone Furoate (FF)/GW642444 Inhalation Powder
200mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) Receives: Drug: Fluticasone Furoate (FF)/GW642444 Inhalation Powder
placebo	Placebo comparator	placebo Receives: Device: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.
Measured: Pre-dose and the end of each 28-day treatment period (up to 19 weeks)

Secondary outcomes (2)

Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period
Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.
Measured: From Baseline to the end of each 28-day treatment period (up to 19 weeks)
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.
Measured: Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20101 Jul 2010

First posted19 Feb 2010 (estimated)
Study start1 Jan 2010
Primary completion1 Jul 2010
Study completion1 Jul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01072149
Sponsor's protocol ID: 110946
Status last verified: Oct 2017
First submitted: 12 Feb 2010
Last updated: 9 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Boscia JA, Pudi KK, Zvarich MT, Sanford L, Siederer SK, Crim C. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012 Aug;34(8):1655-66.e5. doi: 10.1016/j.clinthera.2012.06.005. Epub 2012 Jul 11.
PubMed 22789766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Three-way Incomplete Block Crossover Study to Investigate the 24-hour Pulmonary Function of Three Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder vs. Placebo, in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01072149
Acronym / sponsor ID: 110946
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, Safety, FEV1, Efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jan 2010
Primary completion: 1 Jul 2010 (actual)
Study completion: 1 Jul 2010 (actual)
First posted: 19 Feb 2010 (estimated)
Results: Posted 25 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
50mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Drug: Fluticasone Furoate (FF)/GW642444 Inhalation PowderInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
100mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Drug: Fluticasone Furoate (FF)/GW642444 Inhalation PowderInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
200mcg Fluticasone Furoate (FF)/25mcg GW642444	Experimental	Drug: Fluticasone Furoate (FF)/GW642444 Inhalation PowderInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
placebo	Placebo comparator	Device: placeboplacebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Outpatient/Inpatient; Male or female subjects
Subjects must give their signed and dated written informed consent to participate.
A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic, > 45 years, in the absence of hormone replacement therapy. However in questionable cases, a blood sample with FSH >40MIU/ml and estradiol < 40pg/ml (<140 pmol/L) is confirmatory.
OR
Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):

Key exclusion criteria (26 listed)

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone Furoate (FF)/GW642444 Inhalation PowderInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD	Drug	100mcg Fluticasone Furoate (FF)/25mcg GW642444, 200mcg Fluticasone Furoate (FF)/25mcg GW642444, 50mcg Fluticasone Furoate (FF)/25mcg GW642444
placeboplacebo	Device	placebo

Primary outcome

Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period
Time frame: Pre-dose and the end of each 28-day treatment period (up to 19 weeks)
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.

2 secondary outcomes

Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period
Time frame: From Baseline to the end of each 28-day treatment period (up to 19 weeks)
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
Time frame: Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)

Results and safety

Results posted to the registry on 25 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg	3	3
Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg	3	3
Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo	3	2
Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg	3	3
Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo	3	3
Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo	3	3
Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg	3	3
Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg	3	3
Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo	3	3
Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg	3	3
Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg	3	2
Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg	3	3
Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg	3	3
Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo	3	3
Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo	3	3
Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg	3	3
Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg	3	3
Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg	3	2

Primary outcome: Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period

Time frame: Pre-dose and the end of each 28-day treatment period (up to 19 weeks). Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 48	FF/VI 50/25 µg n = 32	FF/VI 100/25 µg n = 30	FF/VI 200/25 µg n = 30
Value	1.297 (0.0240)	1.530 (0.0276)	1.517 (0.0282)	1.533 (0.0282)

Placebo vs FF/VI 50/25 µg: Median Difference (Final Values): 0.233 (95% CI 0.179 to 0.287), p <0.001, Mixed Models Analysis
Placebo vs FF/VI 100/25 µg: Mean Difference (Final Values): 0.220 (95% CI 0.165 to 0.275), p <0.001, Mixed Models Analysis
Placebo vs FF/VI 200/25 µg: Mean Difference (Final Values): 0.236 (95% CI 0.181 to 0.291), p <0.001, Mixed Models Analysis

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 51 (0%)	2 of 51 (3.9%)	Not reported
FF/VI 50/25 µg	0 of 34 (0%)	4 of 34 (11.8%)	Not reported
FF/VI 100/25 µg	0 of 33 (0%)	4 of 33 (12.1%)	Not reported
FF/VI 200/25 µg	0 of 31 (0%)	3 of 31 (9.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22789766Boscia JA, Pudi KK, Zvarich MT, Sanford L, Siederer SK, Crim C. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012 Aug;34(8):1655-66.e5. doi: 10.1016/j.clinthera.2012.06.005. Epub 2012 Jul 11.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate (FF)/GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period (time frame: Pre-dose and the end of each 28-day treatment period (up to 19 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01072149, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.