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Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

8 september 2017 uppdaterad av: GlaxoSmithKline

Multicentre Dose Ranging Study for Once Daily GSK233705 in COPD

The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

576

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Tucuman, Argentina, 4000
        • GSK Investigational Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, CP1900
        • GSK Investigational Site
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • GSK Investigational Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • GSK Investigational Site
      • Pergamino, Buenos Aires, Argentina, 2700
        • GSK Investigational Site
  • Bulgarien
      • Dimitrovgrad, Bulgarien, 6400
        • GSK Investigational Site
      • Ruse, Bulgarien, 7000
        • GSK Investigational Site
      • Sofia, Bulgarien, 1431
        • GSK Investigational Site
      • Sofia, Bulgarien
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7500551
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500691
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
  • Filippinerna
      • Cavite, Filippinerna, 4114
        • GSK Investigational Site
      • Quezon City, Filippinerna, 1100
        • GSK Investigational Site
      • Quezon City, Filippinerna, 1109
        • GSK Investigational Site
  • Förenta staterna
    • Alabama
      • Jasper, Alabama, Förenta staterna, 35501
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, Förenta staterna, 85306
        • GSK Investigational Site
    • California
      • Fountain Valley, California, Förenta staterna, 92708
        • GSK Investigational Site
      • Fullerton, California, Förenta staterna, 92835
        • GSK Investigational Site
      • Los Angeles, California, Förenta staterna, 90095
        • GSK Investigational Site
      • Los Angeles, California, Förenta staterna, 90048
        • GSK Investigational Site
      • Riverside, California, Förenta staterna, 92506
        • GSK Investigational Site
      • Roseville, California, Förenta staterna, 95661
        • GSK Investigational Site
      • San Diego, California, Förenta staterna, 92103-8415
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, Förenta staterna, 33511
        • GSK Investigational Site
      • Panama City, Florida, Förenta staterna, 32405
        • GSK Investigational Site
      • South Miami, Florida, Förenta staterna, 33143
        • GSK Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, Förenta staterna, 83814
        • GSK Investigational Site
    • Kentucky
      • Madisonville, Kentucky, Förenta staterna, 42431
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Förenta staterna, 70503
        • GSK Investigational Site
      • Sunset, Louisiana, Förenta staterna, 70584
        • GSK Investigational Site
    • Missouri
      • Saint Charles, Missouri, Förenta staterna, 63301
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28207
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29406-7108
        • GSK Investigational Site
      • Greenville, South Carolina, Förenta staterna, 29615
        • GSK Investigational Site
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • GSK Investigational Site
      • Union, South Carolina, Förenta staterna, 29379
        • GSK Investigational Site
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • GSK Investigational Site
    • Virginia
      • Abingdon, Virginia, Förenta staterna, 24210
        • GSK Investigational Site
      • Richmond, Virginia, Förenta staterna, 23229
        • GSK Investigational Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N1
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Kanada, A0A 1G0
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Kanada, L5A 3V4
        • GSK Investigational Site
      • Ottawa, Ontario, Kanada, K1H 8L6
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M5G 1N8
        • GSK Investigational Site
    • Quebec
      • Saint Romuald, Quebec, Kanada, G6W 5M6
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Kanada, J7Z 5T3
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Kanada, G1V 4G5
        • GSK Investigational Site
  • Korea, Republiken av
      • Seoul, Korea, Republiken av, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republiken av, 133--792
        • GSK Investigational Site
  • Nederländerna
      • Almelo, Nederländerna, 7609 PP
        • GSK Investigational Site
      • Eindhoven, Nederländerna, 5623 EJ
        • GSK Investigational Site
      • Hoofddorp, Nederländerna, 2134 TM
        • GSK Investigational Site
      • Hoorn, Nederländerna, 1624 NP
        • GSK Investigational Site
  • Rumänien
      • Brasov, Rumänien, 500112
        • GSK Investigational Site
      • Bucharest, Rumänien, 020125
        • GSK Investigational Site
      • Iasi, Rumänien, 700115
        • GSK Investigational Site
  • Storbritannien
      • London, Storbritannien, SE5 9PJ
        • GSK Investigational Site
      • Norwich, Storbritannien, NR4 7UY
        • GSK Investigational Site
    • Sussex East
      • Brighton, Sussex East, Storbritannien, BN2 5BE
        • GSK Investigational Site
  • Sydafrika
      • Bellville, Sydafrika, 7531
        • GSK Investigational Site
      • Mowbray, Sydafrika, 7700
        • GSK Investigational Site
    • Gauteng
      • Cape Town, Gauteng, Sydafrika, 7505
        • GSK Investigational Site
      • Mueckelneck, Gauteng, Sydafrika, 0001
        • GSK Investigational Site
      • Parktown, Gauteng, Sydafrika, 2193
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
      • Chiangmai, Thailand, 50200
        • GSK Investigational Site
      • Khon Kaen, Thailand, 40002
        • GSK Investigational Site
      • Songkla, Thailand, 90110
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 14057
        • GSK Investigational Site
      • Berlin, Tyskland, 10117
        • GSK Investigational Site
      • Berlin, Tyskland, 10717
        • GSK Investigational Site
      • Berlin, Tyskland, 10787
        • GSK Investigational Site
      • Berlin, Tyskland, 10559
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Wiesloch, Baden-Wuerttemberg, Tyskland, 69168
        • GSK Investigational Site
    • Hessen
      • Gelnhausen, Hessen, Tyskland, 63571
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Tyskland, 30167
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Tyskland, 23552
        • GSK Investigational Site
    • Thueringen
      • Schmoelln, Thueringen, Tyskland, 04626
        • GSK Investigational Site
  • Ungern
      • Balassagyarmat, Ungern, 2660
        • GSK Investigational Site
      • Budapest, Ungern, 1095
        • GSK Investigational Site
      • Budapest, Ungern, H-1529
        • GSK Investigational Site
      • Mátraháza, Ungern, 3233
        • GSK Investigational Site

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 till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • A signed and dated written informed consent prior to study participation.
  • Male or female adults.

A female is eligible to enter and participate in this study if she is of:

non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact)

  • 40 to 80 years of age at Visit 1
  • An established clinical history of COPD
  • Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1.
  • A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

  • Women who are pregnant or lactating.
  • A current diagnosis of asthma.
  • Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
  • Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy)
  • Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD.
  • Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1.
  • Hospitalization for COPD or pneumonia within 3 months prior to Visit 1.
  • Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1.
  • Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities.
  • An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem.
  • Positive for Hepatitis B or Hepatitis C at Visit 1.
  • A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1
  • A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate.
  • Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric.
  • Medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after Visit 3).
  • Additional Medications: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit 1.
  • Use of long-term oxygen therapy (LTOT) or supplemental oxygen required for greater than 12 hours a day. Oxygen use as needed is not exclusionary.
  • Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP)
  • Use of regular nebulized therapy
  • Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV)
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
  • An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study
  • History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
  • Use of GSK233705B in previous studies.

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
Experimentell: Arm 1
GSK233705 12.5mcg
Läkemedel: GSK233705 12.5mcg
Once daily via dry powder inhaler
Experimentell: Arm 2
GSK233705 25mcg
Läkemedel: GSK233705 25mcg
once daily via dry powder inhaler
Experimentell: Arm 3
GSK233705 50mcg
Läkemedel: GSK233705 50mcg
Once daily via dry powder inhaler
Experimentell: Arm 4
GSK233705 100mcg
Läkemedel: GSK233705 100mcg
Once daily via dry powder inhaler
Experimentell: Arm 5
GSK233705 200mcg
Läkemedel: GSK233705 200mcg
Once daily via dry powder inhaler
Placebo-jämförare: Arm 6
Placebo
Läkemedel: Placebo
Once daily via dry powder imhaler

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Tidsram: Baseline (pre-dose Day 1) and Day 29
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
Baseline (pre-dose Day 1) and Day 29

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29
Tidsram: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.
Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29
Tidsram: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.
Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Change From Baseline in Clinic Visit Trough FVC on Day 29
Tidsram: Baseline (pre-dose Day 1) and Day 29
The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
Baseline (pre-dose Day 1) and Day 29

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

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.

Allmänna publikationer

Användbara länkar

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 (Faktisk)

16 maj 2008

Primärt slutförande (Faktisk)

22 december 2008

Avslutad studie (Faktisk)

22 december 2008

Studieregistreringsdatum

Först inskickad

8 maj 2008

Först inskickad som uppfyllde QC-kriterierna

8 maj 2008

Första postat (Uppskatta)

12 maj 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AC2110664

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

  1. Annoterad fallrapportformulär
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokoll
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk studierapport
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analysplan
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datauppsättning för individuella deltagare
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datauppsättningsspecifikation
    Informationsidentifierare: AC2110664
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informerat samtycke
    Informationsidentifierare: AC2110664
    Informationskommentarer: 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 .

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