Last updated: 11/07/2018 04:32:22
Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components 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 subject 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 (h) 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 Inhalation Powder
Drug: FF/GW642444 Inhalation Powder
Drug: GW642444 Inhalation Powder
Drug: Placebo
Enrollment:
1226
Observational study model:
Not applicable
Primary completion date:
2011-08-02
Time perspective:
Not applicable
Clinical publications:
Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PMA. Fluticasone furoate/vilanterol (100/25; 200/25 µg) improves lung function in COPD: A randomised trial. Respir Med. 2013;107(4):550-559.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, vilanterol
Collaborators
Not applicable
Study date(s)
October 2009 to February 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
New Tazewell, Tennessee, United States, 37825
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Study Complete
Location
GSK Investigational Site
Cipolletti, Río Negro, Argentina, R8324EMB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29203
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fredericksburg, Virginia, United States, 22401
Status
Study Complete
Location
GSK Investigational Site
Martinez, Georgia, United States, 30907
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Kralupy nad Vltavou, Czech Republic, 278 01
Status
Study Complete
Location
GSK Investigational Site
Lakewood, California, United States, 90712
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Monterey Park, California, United States, 91754
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wilmington, Delaware, United States, 19805
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11229
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32503
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
Tulsa, Oklahoma, United States, 74136-8303
Status
Study Complete
Location
GSK Investigational Site
Bay Pines, Florida, United States, 33744
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030-5841
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 7712
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70868
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
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
2011-08-02
Actual study completion date
2011-08-02
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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