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

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: UK-432,097; Drug: Placebo

• Registration Number: NCT00430300
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2011-03-16
• Disposition First Submitted QC: 2011-03-16
• Disposition First Posted: 2011-03-28
• Status Verified: 2013-05
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Results First Posted: 2013-07-08
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 87

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150mcg, 450mcg or 1350mcg	UK-432,097	Active treatment given BID via a double pin monodose capsule inhaler device
Placebo	Placebo	Placebo treatment given BID via a single pin monodose inhaler device

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8	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.
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8	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.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8	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.
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8	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.
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6	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.
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6	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.
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6	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.
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6	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.
Change From Baseline in Post-Bronchodilator IC at Week 6	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.
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6	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.
Change From Baseline in Post-Bronchodilator FEV1 at Week 6	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.
Change From Baseline in Post-Bronchodilator FEV6 at Week 6	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.
Change From Baseline in Post-Bronchodilator FVC at Week 6	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.
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8	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.
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8	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.
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8	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.
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)	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.
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Southampton, United Kingdom