Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

17. května 2013 aktualizováno: Pfizer

A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.

Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

87

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • New South Wales
      • Camperdown, New South Wales, Austrálie, 2050
        • Pfizer Investigational Site
      • Glebe, New South Wales, Austrálie, 2037
        • Pfizer Investigational Site
    • South Australia
      • Daw Park, South Australia, Austrálie, 5041
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Austrálie, 6009
        • Pfizer Investigational Site
  • Holandsko
      • Almelo, Holandsko, 7609 PP
        • Pfizer Investigational Site
      • Eindhoven, Holandsko, 5623 EJ
        • Pfizer Investigational Site
      • Zuthpen, Holandsko, 7207 BA
        • Pfizer Investigational Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T1Y 6J4
        • Pfizer Investigational Site
      • Red Deer, Alberta, Kanada, T4N 6V7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3Z5
        • Pfizer Investigational Site
    • Quebec
      • Québec, Quebec, Kanada, G1V 4G5
        • Pfizer Investigational Site
      • Trois-Rivières, Quebec, Kanada, G8T 7A1
        • Pfizer Investigational Site
  • Polsko
      • Bydgoszcz, Polsko, 85-326
        • Pfizer Investigational Site
      • Gdansk, Polsko, 80-952
        • Pfizer Investigational Site
      • Lodz, Polsko, 90-153
        • Pfizer Investigational Site
      • Warszawa, Polsko, 01-138
        • Pfizer Investigational Site
  • Spojené království
      • Leicester, Spojené království, LE3 9QP
        • Pfizer Investigational Site
      • London, Spojené království, E2 9ZY
        • Pfizer Investigational Site
      • Manchester, Spojené království, M23 QZ
        • Pfizer Investigational Site
      • Newcastle upon Tyne, Spojené království, NE7 7DN
        • Pfizer Investigational Site
      • Southampton, Spojené království, SO16 6YD
        • Pfizer Investigational Site
    • Surrey
      • Chertsey, Surrey, Spojené království, KT16 0PZ
        • Pfizer Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
  • Patients must have a smoking history of at least 10 pack-years
  • Patients must have stable disease for at least 1 month prior to screening.

Exclusion Criteria:

  • More than 2 exacerbations of COPD in the preceding year
  • History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
  • History or presence of respiratory failure, cor pulmonale or right ventricular failure

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 150mcg, 450mcg or 1350mcg
Active treatment given BID via a double pin monodose capsule inhaler device
Lék: UK-432,097
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
Komparátor placeba: Placebo
Placebo treatment given BID via a single pin monodose inhaler device
Lék: Placebo
Capsules containing 100% lactose administered BID using an atomizer device

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Časové okno: Pre-dose at Baseline, Week 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Pre-dose at Baseline, Week 6

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Časové okno: Pre-dose at Baseline, Week 2, 4, 8
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Pre-dose at Baseline, Week 2, 4, 8
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
Časové okno: Pre-dose at Baseline, Week 2, 4, 6, 8
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.
Pre-dose at Baseline, Week 2, 4, 6, 8
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
Časové okno: Pre-dose at Baseline, Week 2, 4, 6, 8
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Pre-dose at Baseline, Week 2, 4, 6, 8
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
Časové okno: Pre-dose at Baseline, Week 2, 4, 6, 8
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.
Pre-dose at Baseline, Week 2, 4, 6, 8
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
Časové okno: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
Časové okno: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
Časové okno: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
Časové okno: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
Časové okno: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
Časové okno: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator FVC at Week 6
Časové okno: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator IC at Week 6
Časové okno: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
Časové okno: Baseline, Week 2, 4, 6
BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.
Baseline, Week 2, 4, 6
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
Časové okno: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Časové okno: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
Časové okno: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.
Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
Časové okno: Week 6
CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Week 6
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Časové okno: Week 6
PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Week 6

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
Časové okno: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
Časové okno: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8
Časové okno: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
Časové okno: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.
Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6
Časové okno: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.
Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2007

Primární dokončení (Aktuální)

1. července 2008

Dokončení studie (Aktuální)

1. července 2008

Termíny zápisu do studia

První předloženo

30. ledna 2007

První předloženo, které splnilo kritéria kontroly kvality

31. ledna 2007

První zveřejněno (Odhad)

1. února 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

8. července 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. května 2013

Naposledy ověřeno

1. května 2013

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A3971013

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na UK-432,097

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Belarus

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit