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

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.

Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

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.

Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

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.

Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

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.

Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

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.

Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

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.

Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

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.

Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

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.

Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6

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.

Time frame: Baseline, Week 2, 4, 6

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.

Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

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.

Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

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.

Time frame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

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.

Time frame: Week 6

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.

Time frame: Week 6