Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
2013年5月17日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
87
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Leicester、イギリス、LE3 9QP
- Pfizer Investigational Site
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London、イギリス、E2 9ZY
- Pfizer Investigational Site
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Manchester、イギリス、M23 QZ
- Pfizer Investigational Site
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Newcastle upon Tyne、イギリス、NE7 7DN
- Pfizer Investigational Site
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Southampton、イギリス、SO16 6YD
- Pfizer Investigational Site
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Surrey
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Chertsey、Surrey、イギリス、KT16 0PZ
- Pfizer Investigational Site
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Almelo、オランダ、7609 PP
- Pfizer Investigational Site
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Eindhoven、オランダ、5623 EJ
- Pfizer Investigational Site
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Zuthpen、オランダ、7207 BA
- Pfizer Investigational Site
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New South Wales
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Camperdown、New South Wales、オーストラリア、2050
- Pfizer Investigational Site
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Glebe、New South Wales、オーストラリア、2037
- Pfizer Investigational Site
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South Australia
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Daw Park、South Australia、オーストラリア、5041
- Pfizer Investigational Site
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
- Pfizer Investigational Site
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Alberta
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Calgary、Alberta、カナダ、T1Y 6J4
- Pfizer Investigational Site
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Red Deer、Alberta、カナダ、T4N 6V7
- Pfizer Investigational Site
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Ontario
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Hamilton、Ontario、カナダ、L8N 3Z5
- Pfizer Investigational Site
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Quebec
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Québec、Quebec、カナダ、G1V 4G5
- Pfizer Investigational Site
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Trois-Rivières、Quebec、カナダ、G8T 7A1
- Pfizer Investigational Site
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Bydgoszcz、ポーランド、85-326
- Pfizer Investigational Site
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Gdansk、ポーランド、80-952
- Pfizer Investigational Site
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Lodz、ポーランド、90-153
- Pfizer Investigational Site
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Warszawa、ポーランド、01-138
- Pfizer Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
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協力者と研究者
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スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年1月1日
一次修了 (実際)
2008年7月1日
研究の完了 (実際)
2008年7月1日
試験登録日
最初に提出
2007年1月30日
QC基準を満たした最初の提出物
2007年1月31日
最初の投稿 (見積もり)
2007年2月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年7月8日
QC基準を満たした最後の更新が送信されました
2013年5月17日
最終確認日
2013年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- A3971013
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