Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
17 de maio de 2013 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
87
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New South Wales
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Camperdown, New South Wales, Austrália, 2050
- Pfizer Investigational Site
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Glebe, New South Wales, Austrália, 2037
- Pfizer Investigational Site
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South Australia
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Daw Park, South Australia, Austrália, 5041
- Pfizer Investigational Site
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Western Australia
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Nedlands, Western Australia, Austrália, 6009
- Pfizer Investigational Site
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Alberta
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Calgary, Alberta, Canadá, T1Y 6J4
- Pfizer Investigational Site
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Red Deer, Alberta, Canadá, T4N 6V7
- Pfizer Investigational Site
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- Pfizer Investigational Site
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Quebec
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Québec, Quebec, Canadá, G1V 4G5
- Pfizer Investigational Site
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Trois-Rivières, Quebec, Canadá, G8T 7A1
- Pfizer Investigational Site
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Almelo, Holanda, 7609 PP
- Pfizer Investigational Site
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Eindhoven, Holanda, 5623 EJ
- Pfizer Investigational Site
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Zuthpen, Holanda, 7207 BA
- Pfizer Investigational Site
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Bydgoszcz, Polônia, 85-326
- Pfizer Investigational Site
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Gdansk, Polônia, 80-952
- Pfizer Investigational Site
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Lodz, Polônia, 90-153
- Pfizer Investigational Site
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Warszawa, Polônia, 01-138
- Pfizer Investigational Site
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Leicester, Reino Unido, LE3 9QP
- Pfizer Investigational Site
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London, Reino Unido, E2 9ZY
- Pfizer Investigational Site
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Manchester, Reino Unido, M23 QZ
- Pfizer Investigational Site
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Pfizer Investigational Site
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Southampton, Reino Unido, SO16 6YD
- Pfizer Investigational Site
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Surrey
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Chertsey, Surrey, Reino Unido, KT16 0PZ
- Pfizer Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador de 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2007
Conclusão Primária (Real)
1 de julho de 2008
Conclusão do estudo (Real)
1 de julho de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
30 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de janeiro de 2007
Primeira postagem (Estimativa)
1 de fevereiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de julho de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de maio de 2013
Última verificação
1 de maio de 2013
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A3971013
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .