Last updated: 11/07/2018 06:41:04
A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry with COPD
EudraCT ID
Not applicable
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/Vilanterol Inhalation Powder Delivered Once Daily via a Dry Powder Inhaler Compared with Placebo in Subjects of Asian Ancestry with Chronic Obstructive Pulmonary Disease
Trial description: The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in clinic visit pre-dose trough FEV1 at Day 169
Timeframe: Baseline to Day 169
Secondary outcomes:
Mean change from Baseline in chronic respiratory disease questionnaire self-administered standardized (CRQ-SAS) dyspnea domain score at Day 168
Timeframe: Baseline (BL) and Day 168
Interventions:
Drug: fluticasone furoate/vilanterol
Drug: Placebo
Enrollment:
646
Observational study model:
Not applicable
Primary completion date:
2012-14-09
Time perspective:
Not applicable
Clinical publications:
Zheng J, de Guia T, Wang-Jairaj J, Newlands AH, Wang C, Crim C, Zhong N. Efficacy and safety of fluticasone furoate/vilanterol (50/25mcg; 100/25mcg; 200/25mcg) in Asian patients with chronic obstructive pulmonary disease: A randomised placebo-controlled trial. Curr Med Res Opin. 2015;31(6):1191-1200.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
April 2011 to September 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
- Subjects of Asian ancestry
- Pregnancy
- A current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
- Subjects of Asian ancestry
- Valid informed consent
- Current or former smoker
- > or = 2 on the modified Medical Research Council Dyspnea Scale at Screening
Exclusion criteria:
- Pregnancy
- A current diagnosis of asthma
- alpha1-antitrypsin deficiency as the underlying cause for COPD
- Other active, respiratory disorders
- Have lung volume reduction surgery within 12 months prior to Screening
- A chest X-ray or CT (Computerised Tomography) scan reveals evidence of clinical significant abnormalities not believed to be due to the presence of COPD
- Poorly controlled COPD: acute worsening of COPD managed by corticosteroids, antibiotics, or treatments prescribed by a physician 6 weeks prior to Screening, or requires hospitalisation due to poorly controlled COPD 12 weeks prior to Screening
- Lower respiratory tract infection requires antibiotics within 4 weeks prior to Screening
- Other disease or abnormalities, in the opinion of the investigator, would put the safety of the subject at risk during the study or would affect safety or efficacy analysis if the disease/condition exacerbated during the study
- Subject 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.
- Subject has a history of hypersensitivity to any of the study medications or components of the inhalation powder. Subject has a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded.
- Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
- Subjects who are medically unable to withhold albuterol, ipratropium for 4 hrs and/or theophylline for 12 hrs prior to spirometry testing.
- Subjects use a list of prohibited medications specified in the study protocol, including but not limited to traditional or herbal medications for the treatment of COPD
- Subject requires long-term oxygen therapy or nocturnal oxygen therapy for greater than 12 hours a day
- Pulmonary rehabilitation: subjects who are in the maintenance phase are not excluded.
- Non-compliance
- Questionable validity of the Informed Consent
- Prior use of study medication or other investigational drugs
- Affiliation with investigator site -
Trial location(s)
Location
GSK Investigational Site
Suwon, Gyeonggi-do, South Korea, 442-723
Status
Study Complete
Location
GSK Investigational Site
jeonju-si, Jeollabuk-Do, South Korea, 561-712
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
2012-14-09
Actual study completion date
2012-14-09
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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