DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: FF/VI 100/25 Inhalation Powder NDPI (Drug); Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS (Drug); Placebo Inhalation Powder NDPI (Drug); Placebo Inhalation Powder ACCUHALER/DISKUS (Drug); Salbutamol as needed (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84

Secondary outcome:

Time to Onset on Treatment Day 1

Change From Baseline in Trough FEV1 on Treatment Day 85

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Investigational Site, Berlin 13125, Germany

GSK Investigational Site, Berlin 10717, Germany

GSK Investigational Site, Berlin 10787, Germany

GSK Investigational Site, Berlin 12203, Germany

GSK Investigational Site, Berlin 12157, Germany

GSK Investigational Site, Hamburg 20253, Germany

GSK Investigational Site, Bacau 600114, Romania

GSK Investigational Site, Braila 810003, Romania

GSK Investigational Site, Brasov 500283, Romania

GSK Investigational Site, Brasov 500118, Romania

GSK Investigational Site, Bucharest 030317, Romania

GSK Investigational Site, Bucuresti 70000, Romania

GSK Investigational Site, Cluj Napoca 400371, Romania

GSK Investigational Site, Cluj-Napoca 400371, Romania

GSK Investigational Site, Iasi 700115, Romania

GSK Investigational Site, Pitesti 110084, Romania

GSK Investigational Site, Ploiesti 100379, Romania

GSK Investigational Site, Ramnicu Valcea 240564, Romania

GSK Investigational Site, Suceava 720284, Romania

GSK Investigational Site, Timisoara 300310, Romania

GSK Investigational Site, Chelyabinsk 454106, Russian Federation

GSK Investigational Site, Kemerovo 650002, Russian Federation

GSK Investigational Site, Kemerovo 650099, Russian Federation

GSK Investigational Site, Kursk 305035, Russian Federation

GSK Investigational Site, Novosibirsk 630051, Russian Federation

GSK Investigational Site, Novosibirsk 630102, Russian Federation

GSK Investigational Site, Perm 614077, Russian Federation

GSK Investigational Site, Saint-Petersburg 195271, Russian Federation

GSK Investigational Site, St. Petersburg 194291, Russian Federation

GSK Investigational Site, St. Petersburg 194356, Russian Federation

GSK Investigational Site, Ulyanovsk 432063, Russian Federation

GSK Investigational Site, Vladivostok 690002, Russian Federation

GSK Investigational Site, Yaroslavl 150003, Russian Federation

GSK Investigational Site, Kharkiv 61035, Ukraine

GSK Investigational Site, Kiev 03680, Ukraine

GSK Investigational Site, Kyiv 03680, Ukraine

GSK Investigational Site, Kyiv 04201, Ukraine

GSK Investigational Site, Cottbus, Brandenburg 03050, Germany

GSK Investigational Site, Clearwater, Florida 33765, United States

GSK Investigational Site, DeLand, Florida 32720, United States

GSK Investigational Site, Frankfurt, Hessen 60389, Germany

GSK Investigational Site, Frankfurt, Hessen 60596, Germany

GSK Investigational Site, Neu isenburg, Hessen 63263, Germany

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States

GSK Investigational Site, Normal, Illinois 61761, United States

GSK Investigational Site, Woodbury, Minnesota 55125, United States

GSK Investigational Site, Hannover, Niedersachsen 30159, Germany

GSK Investigational Site, Hannover, Niedersachsen 30173, Germany

GSK Investigational Site, Charlotte, North Carolina 28207, United States

GSK Investigational Site, Columbus, Ohio 43215, United States

GSK Investigational Site, Delitzsch, Sachsen 04509, Germany

GSK Investigational Site, Dresden, Sachsen 01069, Germany

GSK Investigational Site, Leipzg, Sachsen 04109, Germany

GSK Investigational Site, Leipzig, Sachsen 04207, Germany

GSK Investigational Site, Easley, South Carolina 29640, United States

GSK Investigational Site, Gaffney, South Carolina 29340, United States

GSK Investigational Site, Greenville, South Carolina 29615, United States

GSK Investigational Site, Orangeburg, South Carolina 29118, United States

GSK Investigational Site, Rock Hill, South Carolina 29732, United States

GSK Investigational Site, Seneca, South Carolina 29678, United States

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Union, South Carolina 29379, United States

GSK Investigational Site, Renton, Washington 98055, United States

Additional Information

Starting date: October 2012
Last updated: July 24, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017