Last updated: 11/07/2018 04:30:59
A 6-month study to evaluate the efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in weighted mean FEV1 over 0-4 hours post-dose at Day 168
Timeframe: Baseline (BL) to Day 168
Change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Day 169
Timeframe: Baseline to Day 169
Secondary outcomes:
Change from Baseline in chronic respiratory disease questionnaire self-administered standardized (CRQ-SAS) dyspnea score at Day 168
Timeframe: Baseline to Day 168
Change from Baseline in peak post-dose FEV1 (0-4 hour) on Day 1
Timeframe: Baseline and Day 1
Time to onset (increase of 100 milliliter [mL] from Baseline in 0-4 hours post-dose FEV1) on Treatment Day 1
Timeframe: Baseline and Day 1
Interventions:
Drug: FF/GW642444 Inhalation Powder
Drug: FF Inhalation Powder
Drug: GW642444 Inhalation Powder
Drug: Placebo
Enrollment:
1031
Observational study model:
Not applicable
Primary completion date:
2011-14-04
Time perspective:
Not applicable
Clinical publications:
Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 µg; 100/25 µg) on lung function in COPD. Respir Med. 2013;107(4):560-569.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, vilanterol
Collaborators
Not applicable
Study date(s)
October 2009 to April 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Type of subject: outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Type of subject: outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of:
- Non-child bearing potential OR
- Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
- Age: ≥40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
- Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
- Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
- FEV1/FVC ratio of ≤0.70 and
- FEV1 ≤70% of predicted normal values
- Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).
Exclusion criteria:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: Subjects with a current diagnosis of asthma
- α1-antitrypsin deficiency: Subjects with α1-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 (Visit 1)
- Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
- Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
- Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
- Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to 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.
- 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 medication or components of the inhalation powder
- 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 and/or their ipratropium 4 hours prior to spirometry testing at each study visit
- Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified 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 (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
- 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
- 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 location(s)
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Monterrey NL, Nuevo León, Mexico, 64718
Status
Study Complete
Location
GSK Investigational Site
Fall River, Massachusetts, United States, 02720
Status
Study Complete
Location
GSK Investigational Site
Uijeongbu-si, Kyonggi-do, South Korea, 480-130
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Livonia, Michigan, United States, 48152
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7601003
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44263
Status
Study Complete
Location
GSK Investigational Site
Maitland, Florida, United States, 32751
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80802
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76309
Status
Study Complete
Location
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64060
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pelzer, South Carolina, United States, 29669
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Study Complete
Location
GSK Investigational Site
Goerlitz, Sachsen, Germany, 02826
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Edina, Minnesota, United States, 55438
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33755
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63117
Status
Study Complete
Location
GSK Investigational Site
Shakhty, Rostov region, Russia, 346510
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
Sepulveda, California, United States, 91343
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
Completed
Actual primary completion date
2011-14-04
Actual study completion date
2011-14-04
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.
Additional information about the trial
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