| Primary | Participants With Treatment-Emergent Adverse Events | Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. | | Posted | | Number | | participants | | Day 1 to Day 49 (study termination) | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
| | | Title | Denominators | Categories |
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| Any adverse event | | | | Treatment-related adverse event | | |
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| Primary | Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator | A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations. | Safety population. The study was terminated prior to the during study evaluations. | Posted | | | | | | Days -15 to -8 (Screening), Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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| Primary | Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator | Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory. | Safety population. The study was terminated prior to the during study evaluations. | Posted | | | | | | Days -15 to -8 (Screening), Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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| Primary | Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator | A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects. | Safety population. The study was terminated prior to the during study evaluations. | Posted | | | | | | Days -15 to -8 (Screening), Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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| Primary | Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator | Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used. | Safety population. The study was terminated prior to the during study evaluations. | Posted | | | | | | Days -15 to -8 (Screening), Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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| Post-Hoc | Blood Pressure at Screening and End of Study | Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used. | | Posted | | Mean | Standard Deviation | mmHg | | Days -15 to -8 (Screening), up to Day 49 (End of study) | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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| Post-Hoc | Pulse at Screening and End of Study | Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse. | | Posted | | Mean | Standard Deviation | beats/minute | | Days -15 to -8 (Screening), up to Day 49 (End of study) | | | | ID | Title | Description |
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| OG000 | Albuterol Spiromax | Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). | | OG001 | Placebo Spiromax | Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). |
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