A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:5/4/2018
Start Date:October 15, 2012
End Date:June 17, 2013

Use our guide to learn which trials are right for you!

A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week
parallel group study evaluating the effects of once daily in the morning treatment of FF/VI
Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on
lung function in COPD subjects.

Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to
evaluate the subject's adherence with study treatment, study procedures and assessment of
disease stability.

At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the
Randomization Criteria will be randomized to double-blind study medication (12-week treatment
period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone
Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in
NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1
inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening
(approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study
medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return
to the clinic at the end of the treatment period.

A follow-up phone contact will be performed approximately 7 days after the last clinic visit.
The overall study duration (Screening to Follow-up) for each subject is approximately 15
weeks.


Inclusion Criteria:

- A male or female >=40 years of age at Screening (Visit 1).

- Capable of giving written informed consent.

- Female subjects must be post-menopausal or using a highly effective method for
avoidance of pregnancy.

- Subjects with a clinical history of COPD in accordance with the following definition
by the American Thoracic Society/European Respiratory Society.

- Subject with a measured post-albuterol (salbutamol) FEV1/forced vital capacity(FVC)
ratio of <=0.70 at Screening.

- Subjects with a measured post-albuterol (salbutamol) FEV1 <=70% of predicted normal
values.

- Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at
Screening.

Exclusion Criteria:

- Current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if
they have a current diagnosis of COPD).

- Other respiratory disorders (alpha1-antitrypsin deficiency as the underlying cause of
COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary
fibrosis, pulmonary hypertension, interstitial lung diseases, or other active
pulmonary diseases).

- Lung volume reduction surgery within the 12 months prior to Screening.

- Hospitalized due to poorly controlled COPD within 12 weeks of Screening.

- Poorly controlled COPD (occurrence of the following in the 6 weeks prior to Screening
-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 that required the use of antibiotics within 6 weeks
prior to Screening.

- Moderate/severe COPD exacerbation/lower respiratory tract infection during Run-In
Period.

- Abnormal and clinically significant 12-lead ECG at Screening

- Historical or current evidence of uncontrolled or clinically significant disease like
cardiovascular, hypertension, neurological, psychiatric, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic
ulcer disease, or haematological abnormalities. 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.

- History of hypersensitivity to any of the study medications or components of the
inhalation powder; or history of severe milk protein allergy.

- Known or suspected history of alcohol or drug abuse within the last 2 years.

- Subjects who are medically unable to withhold their albuterol (salbutamol) and/or
their ipratropium for the 4-hour period required prior to spirometry testing at each
study visit.

- The subject has taken any other investigational drug within 30 days or 5 half-lives of
the investigational product (IP) prior to the first dosing day in the current study.

- Use of additional medications prior to Screening (list of medications and time
intervals are different for different class of medications and are indicated in the
protocol)

- 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.

- Subjects who have participated in the acute phase of a Pulmonary Rehabilitation
Program within 4 weeks prior to Screening

- Subjects at risk of non-compliance, or unable to comply with study procedures.

- 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.

- Women who are pregnant or lactating or are planning on becoming pregnant during the
study.

- Previously randomized to either the HZC113109 or HZC112352 clinical studies.
We found this trial at
17
sites
Gaffney, South Carolina 29340
?
mi
from
Gaffney, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
?
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cottbus, Brandenburg 03050
?
mi
from
Cottbus,
Click here to add this to my saved trials
DeLand, Florida 32720
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Easley, South Carolina 29640
?
mi
from
Easley, SC
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Normal, Illinois 61761
?
mi
from
Normal, IL
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Renton, Washington 98057
?
mi
from
Renton, WA
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
Seneca, South Carolina 29678
?
mi
from
Seneca, SC
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Union, South Carolina 29379
?
mi
from
Union, SC
Click here to add this to my saved trials
Woodbury, Minnesota 55125
?
mi
from
Woodbury, MN
Click here to add this to my saved trials