Last updated: 11/07/2018 11:16:46
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)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline trough in weighted-mean 24-hour serial forced expiratory volume in one second (FEV1) on Treatment Day 84
Timeframe: Baseline and Day 84
Secondary outcomes:
Time to onset on Treatment Day 1
Timeframe: Baseline and Day 1
Change from Baseline in trough FEV1 on Treatment Day 85
Timeframe: Baseline and Day 85
Interventions:
Enrollment:
828
Primary completion date:
2013-17-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dransfield MT, Feldman G, Korenblat P, LaForce C, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ.Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25mcg) vs twice-daily fluticasone propionate/salmeterol (250/50mcg) in COPD patients.Respir Med.2014;108(8):1171-1179
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
October 2012 to June 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- A male or female >=40 years of age at Screening (Visit 1).
- Capable of giving written informed consent.
- 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).
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Woodbury, Minnesota, United States, 55125
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
Study Complete
Location
GSK Investigational Site
Renton, Washington, United States, 98055
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-17-06
Actual study completion date
2013-17-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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