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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00430300
• Other study ID #: A3971013
• Status: Terminated
• Phase: Phase 2
• First received: January 30, 2007
• Last updated: May 17, 2013
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.
• Placebo
Capsules containing 100% lactose administered BID using an atomizer device

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Daw Park	South Australia
Australia	Pfizer Investigational Site	Glebe	New South Wales
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Québec	Quebec
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	Trois-Rivières	Quebec
Netherlands	Pfizer Investigational Site	Almelo
Netherlands	Pfizer Investigational Site	Eindhoven
Netherlands	Pfizer Investigational Site	Zuthpen
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Warszawa
United Kingdom	Pfizer Investigational Site	Chertsey	Surrey
United Kingdom	Pfizer Investigational Site	Leicester
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Newcastle upon Tyne
United Kingdom	Pfizer Investigational Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Canada,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6	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	No
Other	Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6	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	No
Other	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	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)	No
Other	Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8	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)	No
Other	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	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	No
Primary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at 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	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 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	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 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	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 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	No
Secondary	Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 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	No
Secondary	Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 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	No
Secondary	Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 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	No
Secondary	Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 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	No
Secondary	Change From Baseline in Post-Study Drug IC at Week 2, 4, and 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	No
Secondary	Change From Baseline in Post-Bronchodilator FEV1 at 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	No
Secondary	Change From Baseline in Post-Bronchodilator FEV6 at 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	No
Secondary	Change From Baseline in Post-Bronchodilator FVC at 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	No
Secondary	Change From Baseline in Post-Bronchodilator IC at 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	No
Secondary	Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 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	No
Secondary	Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 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	No
Secondary	Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 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	No
Secondary	Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 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	No
Secondary	Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)	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	No
Secondary	Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)	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	No

External Links

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