A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD
20 november 2016 uppdaterad av: GlaxoSmithKline
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
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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
646
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Quezon City, Filippinerna, 1100
- GSK Investigational Site
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Quezon City, Filippinerna, 1109
- GSK Investigational Site
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Beijing, Kina, 100034
- GSK Investigational Site
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Beijing, Kina, 100191
- GSK Investigational Site
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Beijing, Kina, 100020
- GSK Investigational Site
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Beijing, Kina, 100048
- GSK Investigational Site
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Changsha, Kina, 410013
- GSK Investigational Site
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Chengdu, Kina, 610041
- GSK Investigational Site
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Chongqing, Kina, 400038
- GSK Investigational Site
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Chongqing, Kina, 400037
- GSK Investigational Site
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Shanghai, Kina, 200025
- GSK Investigational Site
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Shanghai, Kina, 200433
- GSK Investigational Site
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Shanghai, Kina, 200080
- GSK Investigational Site
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Tianjin, Kina, 300052
- GSK Investigational Site
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- GSK Investigational Site
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Guangzhou, Guangdong, Kina, 510120
- GSK Investigational Site
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Guangxi
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Nanning, Guangxi, Kina, 530021
- GSK Investigational Site
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Hunan
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Changsha, Hunan, Kina, 410011
- GSK Investigational Site
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Liaoning
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Shenyang, Liaoning, Kina, 110015
- GSK Investigational Site
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Shenyang, Liaoning, Kina, 110001
- GSK Investigational Site
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Shaanxi
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Xian, Shaanxi, Kina, 710032
- GSK Investigational Site
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Xian, Shaanxi, Kina, 710061
- GSK Investigational Site
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Zhejiang
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Hang Zhou, Zhejiang, Kina, 310003
- GSK Investigational Site
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Seoul, Korea, Republiken av, 158-710
- GSK Investigational Site
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Suwon, Gyeonggi-do, Korea, Republiken av, 442-723
- GSK Investigational Site
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jeonju-si, Jeollabuk-Do, Korea, Republiken av, 561-712
- GSK Investigational Site
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Changhua, Taiwan, 500
- GSK Investigational Site
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Kaohsiung, Taiwan, 833
- GSK Investigational Site
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Taichung, Taiwan, 404
- GSK Investigational Site
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Taichung, Taiwan, 40705
- GSK Investigational Site
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Taichung, Taiwan, 40201
- GSK Investigational Site
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Taipei, Taiwan, 100
- GSK Investigational Site
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Taipei, Taiwan, 112
- GSK Investigational Site
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Tau-Yuan County, Taiwan, 333
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: placebo
matchande placebo
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matchande placebo
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Experimentell: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
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Inhaled corticosteroid/long acting beta-agonist
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
Tidsram: Baseline to Day 169
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Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second.
Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit.
Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit.
Change from Baseline was calculated as the average at each clinic visit minus the Baseline value.
Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.
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Baseline to Day 169
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
Tidsram: Baseline (BL) and Day 168
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CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par.
feels he/she has over COPD symptoms); fatigue (how tired the par.
feels); emotional function (how anxious/depressed the par.
feels); and dyspnea (how short of breath the par.
feels during physical activities).
Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment).
Dyspnea domain score is the mean of all non-missing responses for that domain.
Only the dyspnea domain was measured as a secondary outcome.
BL scores are the derived scores for each domain and total at Day 1 pre-dose.
Change from BL was calculated as the average of the Day 168 values minus the BL value.
Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.
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Baseline (BL) and Day 168
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2011
Primärt slutförande (Faktisk)
1 september 2012
Avslutad studie (Faktisk)
1 september 2012
Studieregistreringsdatum
Först inskickad
9 juni 2011
Först inskickad som uppfyllde QC-kriterierna
16 juni 2011
Första postat (Uppskatta)
20 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 januari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdomar
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Dermatologiska medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Anti-allergiska medel
- Flutikason
- Xhance
Andra studie-ID-nummer
- 113684
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Statistisk analysplan
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 113684Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .