Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
17 mai 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
87
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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Camperdown, New South Wales, Australie, 2050
- Pfizer Investigational Site
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Glebe, New South Wales, Australie, 2037
- Pfizer Investigational Site
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South Australia
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Daw Park, South Australia, Australie, 5041
- Pfizer Investigational Site
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Western Australia
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Nedlands, Western Australia, Australie, 6009
- Pfizer Investigational Site
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Alberta
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Calgary, Alberta, Canada, T1Y 6J4
- Pfizer Investigational Site
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Red Deer, Alberta, Canada, T4N 6V7
- Pfizer Investigational Site
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Pfizer Investigational Site
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- Pfizer Investigational Site
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Pfizer Investigational Site
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Almelo, Pays-Bas, 7609 PP
- Pfizer Investigational Site
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Eindhoven, Pays-Bas, 5623 EJ
- Pfizer Investigational Site
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Zuthpen, Pays-Bas, 7207 BA
- Pfizer Investigational Site
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Bydgoszcz, Pologne, 85-326
- Pfizer Investigational Site
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Gdansk, Pologne, 80-952
- Pfizer Investigational Site
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Lodz, Pologne, 90-153
- Pfizer Investigational Site
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Warszawa, Pologne, 01-138
- Pfizer Investigational Site
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Leicester, Royaume-Uni, LE3 9QP
- Pfizer Investigational Site
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London, Royaume-Uni, E2 9ZY
- Pfizer Investigational Site
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Manchester, Royaume-Uni, M23 QZ
- Pfizer Investigational Site
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Newcastle upon Tyne, Royaume-Uni, NE7 7DN
- Pfizer Investigational Site
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Southampton, Royaume-Uni, SO16 6YD
- Pfizer Investigational Site
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Surrey
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Chertsey, Surrey, Royaume-Uni, KT16 0PZ
- Pfizer Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 150mcg, 450mcg or 1350mcg
Active treatment given BID via a double pin monodose capsule inhaler device
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Formulated as a dry powder, supplied as capsules and administered using an atomizer device.
Given as either 150mcg, 450mcg or 1350mcg BID.
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Comparateur placebo: Placebo
Placebo treatment given BID via a single pin monodose inhaler device
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Capsules containing 100% lactose administered BID using an atomizer device
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Délai: Pre-dose at Baseline, Week 6
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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.
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Pre-dose at Baseline, Week 6
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Délai: Pre-dose at Baseline, Week 2, 4, 8
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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.
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Pre-dose at Baseline, Week 2, 4, 8
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Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
Délai: Pre-dose at Baseline, Week 2, 4, 6, 8
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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.
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
Délai: Pre-dose at Baseline, Week 2, 4, 6, 8
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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.
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
Délai: Pre-dose at Baseline, Week 2, 4, 6, 8
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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.
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
Délai: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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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.
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
Délai: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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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.
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
Délai: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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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.
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
Délai: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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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.
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Change From Baseline in Post-Bronchodilator FEV1 at Week 6
Délai: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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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.
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Change From Baseline in Post-Bronchodilator FEV6 at Week 6
Délai: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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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.
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Change From Baseline in Post-Bronchodilator FVC at Week 6
Délai: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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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.
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Change From Baseline in Post-Bronchodilator IC at Week 6
Délai: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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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.
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
Délai: Baseline, Week 2, 4, 6
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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.
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Baseline, Week 2, 4, 6
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Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
Délai: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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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.
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Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Délai: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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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.
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Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
Délai: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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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.
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Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
Délai: Week 6
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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.
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Week 6
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Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Délai: Week 6
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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.
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Week 6
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
Délai: 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
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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).
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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
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Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
Délai: 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
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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.
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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
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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
Délai: 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)
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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).
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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)
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Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
Délai: 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)
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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.
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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)
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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
Délai: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
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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.
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Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2007
Achèvement primaire (Réel)
1 juillet 2008
Achèvement de l'étude (Réel)
1 juillet 2008
Dates d'inscription aux études
Première soumission
30 janvier 2007
Première soumission répondant aux critères de contrôle qualité
31 janvier 2007
Première publication (Estimation)
1 février 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 juillet 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mai 2013
Dernière vérification
1 mai 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A3971013
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .