| 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. | Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG002 | UK-432,097 1350 Mcg | UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG003 | Placebo | Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
| | Units | Counts |
|---|
| Participants | - OG00016
- OG00117
- OG00232
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline (n= 16, 17, 32, 16) | | | Title | Measurements |
|---|
| - OG0001.40± 0.45
- OG0011.48± 0.57
- OG0021.41± 0.39
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo. | Bayesian NDLM model | | 0.0284 | | NDLM estimate difference | -0.0087 | | | 2-Sided | 95 | -0.0943 | 0.0774 | | | | No | Superiority or Other | | | |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Baseline, Week 2, 4, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Baseline, Week 2, 4, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Baseline, Week 2, 4, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | Pre-dose at Baseline, Week 2, 4, 6, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter | | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'N'(number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | liter | | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | |
|
| 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. | Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | puffs/day | | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively. | Posted | | Mean | Standard Deviation | liter per minute | | Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
|
| 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. | FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
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| Other Pre-specified | 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). | Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. | Posted | | Mean | Standard Deviation | 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 | | | | ID | Title | Description |
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| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
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| Other Pre-specified | 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. | Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | 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 | | | | ID | Title | Description |
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| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | |
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| Other Pre-specified | 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). | Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | 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) | | | | ID | Title | Description |
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| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 |
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| Other Pre-specified | 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. | Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. | Posted | | Mean | Standard Deviation | bpm | | 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) | | | | ID | Title | Description |
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| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
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| Other Pre-specified | 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. | Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis. | Posted | | | | | | Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6 | | | | ID | Title | Description |
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| OG000 | UK-432,097 150 Mcg | UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | | OG001 | UK-432,097 450 Mcg | UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. |
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