Trial Outcomes & Findings for Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03256695)

Last Updated: 2021-11-09

Results Overview

CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams \[mg\] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

405 participants

Primary outcome timeframe

Baseline (Day 1) to Week 12

Results posted on

2021-11-09

Participant Flow

A total of 423 participants with exacerbation-prone chronic obstructive pulmonary disease (COPD) were screened, of which 405 participants at 40 investigational centers in the United States met entry criteria and were considered to be eligible for enrollment into the study.

Participant milestones

Participant milestones
Measure	ABS eMDPI Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Study STARTED	405
Overall Study Used ABS eMDPI at Least Once	390
Overall Study COMPLETED	366
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	ABS eMDPI Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Overall Study Adverse Event	8
Overall Study Death	2
Overall Study Withdrawal by Subject	14
Overall Study Non-compliance with study drug	1
Overall Study Lost to Follow-up	3
Overall Study Lack of Efficacy	3
Overall Study Protocol Violation	5
Overall Study Other than specified	3

Baseline Characteristics

Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABS eMDPI n=405 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Age, Continuous	65.6 years STANDARD_DEVIATION 8.70 • n=5 Participants
Sex: Female, Male Female	220 Participants n=5 Participants
Sex: Female, Male Male	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	371 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants
Race (NIH/OMB) White	365 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Number of COPD Exacerbations in the Past 12 Months	1.5 exacerbations STANDARD_DEVIATION 0.98 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during study Day 1 through study Day 7 were excluded from the analysis.

Outcome measures

Outcome measures
Measure	ABS eMDPI n=396 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD	28 percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: ITT analysis set:all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. 'Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD.

Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, office visit, urgent care visit, or emergency care visit), but not a hospitalization. Total number of inhalations taken in 1 day(24-hour period on day prior to date of CE-COPD symptom peak) and at 3,5,7,10,14, and 21 days preceding the date of CE-COPD symptom peak were reported. If a participant experienced multiple CE-COPD events, number of inhalations preceding symptom peak of a subsequent event was counted since end of previous event. Average of inhalations of all events were presented.

Outcome measures

Outcome measures
Measure	ABS eMDPI n=109 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 1 prior to CE-COPD symptom peak	3.7 inhalations Standard Deviation 4.36
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 3 prior to CE-COPD symptom peak	3.5 inhalations Standard Deviation 4.61
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 5 prior to CE-COPD symptom peak	4.2 inhalations Standard Deviation 5.35
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 7 prior to CE-COPD symptom peak	3.4 inhalations Standard Deviation 4.45
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 10 prior to CE-COPD symptom peak	3.2 inhalations Standard Deviation 4.41
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 14 prior to CE-COPD symptom peak	3.4 inhalations Standard Deviation 4.42
Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event Day 21 prior to CE-COPD symptom peak	3.1 inhalations Standard Deviation 4.54

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. 'Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD. 'Number analyzed'=participants evaluable for specified categories. Participants with CE-COPD during Day 1 to Day 7 were excluded.

CE-COPD: occurrence of moderate or severe CE-COPD. Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit), but not a hospitalization. Number of days of increased albuterol use prior to the symptom peak of a CE-COPD was reported for first increase of daily albuterol use; 2 and 4 inhalations in a single day from baseline. increased daily albuterol use was defined as single-day increase of greater than (\>) 20 percent (%) from baseline.

Outcome measures

Outcome measures
Measure	ABS eMDPI n=109 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased Days from albuterol use >20% increase to CE-COPD	32.7 days Standard Deviation 19.92
Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased Days from 2 inhalations increase to CE-COPD	31.2 days Standard Deviation 21.30
Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased Days from 4 inhalations increase to CE-COPD	30.4 days Standard Deviation 21.24

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. 'Overall number of participants analyzed' = participants who experienced at least 1 moderate or severe CE-COPD and reported albuterol use in the 24 hours preceding a moderate or severe CE-COPD.

CE-COPD referred to occurrence of moderate or severe CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization. Number of albuterol inhalations used in the 24 hours preceding a moderate or severe CE-COPD was reported.

Outcome measures

Outcome measures
Measure	ABS eMDPI n=109 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD	3.7 inhalations/24 hours Standard Deviation 4.36

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.

AE was defined 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 investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

Outcome measures

Outcome measures
Measure	ABS eMDPI n=405 Participants Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Number of Participants With Adverse Events (AEs) Any AEs	190 Participants
Number of Participants With Adverse Events (AEs) Severe AEs	43 Participants
Number of Participants With Adverse Events (AEs) Treatment-related AEs	2 Participants
Number of Participants With Adverse Events (AEs) Treatment-related severe AE	0 Participants
Number of Participants With Adverse Events (AEs) Serious AEs	44 Participants
Number of Participants With Adverse Events (AEs) AEs leading to discontinuation from study	8 Participants
Number of Participants With Adverse Events (AEs) CE-COPD related AEs	118 Participants
Number of Participants With Adverse Events (AEs) Device-related AEs	0 Participants
Number of Participants With Adverse Events (AEs) AEs leading to death	2 Participants

Adverse Events

ABS eMDPI

Serious events: 44 serious events

Other events: 94 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	ABS eMDPI n=405 participants at risk Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Infections and infestations Rhinovirus infection	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Acute left ventricular failure	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Acute myocardial infarction	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Angina pectoris	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Atrial fibrillation	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Bradycardia	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Cardiac arrest	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Cardiac failure congestive	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Cardiomyopathy	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Left ventricular failure	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Cardiac disorders Myocardial infarction	0.49% 2/405 • Number of events 2 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Gastrointestinal disorders Diarrhoea	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
General disorders Chest pain	0.49% 2/405 • Number of events 2 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Hepatobiliary disorders Cholelithiasis	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Diverticulitis	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Influenza	0.49% 2/405 • Number of events 2 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Osteomyelitis acute	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Pneumonia	1.2% 5/405 • Number of events 5 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Pneumonia staphylococcal	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Pneumonia viral	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Infections and infestations Sepsis	0.49% 2/405 • Number of events 2 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Injury, poisoning and procedural complications Burns first degree	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Investigations Influenza A virus test positive	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Investigations Influenza B virus test positive	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Metabolism and nutrition disorders Dehydration	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Musculoskeletal and connective tissue disorders Arthralgia	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Nervous system disorders Metabolic encephalopathy	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Nervous system disorders Syncope	0.49% 2/405 • Number of events 2 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Nervous system disorders Transient ischaemic attack	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Psychiatric disorders Substance use disorder	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.2% 5/405 • Number of events 6 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.4% 22/405 • Number of events 24 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.25% 1/405 • Number of events 1 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.

Other adverse events

Other adverse events
Measure	ABS eMDPI n=405 participants at risk Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	23.2% 94/405 • Number of events 104 • AEs were collected from signature of the informed consent form (ICF) to Week 12. AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER