Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 858 for:    ALBUTEROL

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256695
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Intervention Drug: Albuterol sulfate (ABS)
Enrollment 405
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 405
Used ABS eMDPI at Least Once 390
Completed 366
Not Completed 39
Reason Not Completed
Adverse Event             8
Death             2
Withdrawal by Subject             14
Non-compliance with study drug             1
Lost to Follow-up             3
Lack of Efficacy             3
Protocol Violation             5
Other than specified             3
Arm/Group Title ABS eMDPI
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 405
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) analysis set included all enrolled participants regardless of whether a participant took any investigational medicinal product (IMP).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 405 participants
65.6  (8.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
Female
220
  54.3%
Male
185
  45.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
Hispanic or Latino
34
   8.4%
Not Hispanic or Latino
371
  91.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
American Indian or Alaska Native
1
   0.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
Black or African American
38
   9.4%
White
365
  90.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Number of COPD Exacerbations in the Past 12 Months  
Mean (Standard Deviation)
Unit of measure:  Exacerbations
Number Analyzed 405 participants
1.5  (0.98)
1.Primary Outcome
Title Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD
Hide Description

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.

Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 396
Measure Type: Number
Unit of Measure: percentage of participants
28
2.Primary Outcome
Title Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: inhalations
Day 1 prior to CE-COPD symptom peak 3.7  (4.36)
Day 3 prior to CE-COPD symptom peak 3.5  (4.61)
Day 5 prior to CE-COPD symptom peak 4.2  (5.35)
Day 7 prior to CE-COPD symptom peak 3.4  (4.45)
Day 10 prior to CE-COPD symptom peak 3.2  (4.41)
Day 14 prior to CE-COPD symptom peak 3.4  (4.42)
Day 21 prior to CE-COPD symptom peak 3.1  (4.54)
3.Primary Outcome
Title Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: days
Days from albuterol use >20% increase to CE-COPD Number Analyzed 96 participants
32.7  (19.92)
Days from 2 inhalations increase to CE-COPD Number Analyzed 66 participants
31.2  (21.30)
Days from 4 inhalations increase to CE-COPD Number Analyzed 50 participants
30.4  (21.24)
4.Primary Outcome
Title Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: inhalations/24 hours
3.7  (4.36)
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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’.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.
Arm/Group Title ABS eMDPI
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 405
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
190
  46.9%
Severe AEs
43
  10.6%
Treatment-related AEs
2
   0.5%
Treatment-related severe AE
0
   0.0%
Serious AEs
44
  10.9%
AEs leading to discontinuation from study
8
   2.0%
CE-COPD related AEs
118
  29.1%
Device-related AEs
0
   0.0%
AEs leading to death
2
   0.5%
Time Frame AEs were collected from signature of the informed consent form (ICF) to Week 12.
Adverse Event Reporting Description 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.
 
Arm/Group Title ABS eMDPI
Hide Arm/Group Description 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.
All-Cause Mortality
ABS eMDPI
Affected / at Risk (%)
Total   2/405 (0.49%)    
Show Serious Adverse Events Hide Serious Adverse Events
ABS eMDPI
Affected / at Risk (%) # Events
Total   44/405 (10.86%)    
Cardiac disorders   
Acute left ventricular failure  1  1/405 (0.25%)  1
Acute myocardial infarction  1  1/405 (0.25%)  1
Angina pectoris  1  1/405 (0.25%)  1
Atrial fibrillation  1  1/405 (0.25%)  1
Bradycardia  1  1/405 (0.25%)  1
Cardiac arrest  1  1/405 (0.25%)  1
Cardiac failure congestive  1  1/405 (0.25%)  1
Cardiomyopathy  1  1/405 (0.25%)  1
Left ventricular failure  1  1/405 (0.25%)  1
Myocardial infarction  1  2/405 (0.49%)  2
Gastrointestinal disorders   
Diarrhoea  1  1/405 (0.25%)  1
General disorders   
Chest pain  1  2/405 (0.49%)  2
Hepatobiliary disorders   
Cholelithiasis  1  1/405 (0.25%)  1
Infections and infestations   
Diverticulitis  1  1/405 (0.25%)  1
Influenza  1  2/405 (0.49%)  2
Osteomyelitis acute  1  1/405 (0.25%)  1
Pneumonia  1  5/405 (1.23%)  5
Pneumonia staphylococcal  1  1/405 (0.25%)  1
Pneumonia viral  1  1/405 (0.25%)  1
Rhinovirus infection  1  1/405 (0.25%)  1
Sepsis  1  2/405 (0.49%)  2
Injury, poisoning and procedural complications   
Burns first degree  1  1/405 (0.25%)  1
Investigations   
Influenza A virus test positive  1  1/405 (0.25%)  1
Influenza B virus test positive  1  1/405 (0.25%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/405 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/405 (0.25%)  1
Nervous system disorders   
Metabolic encephalopathy  1  1/405 (0.25%)  1
Syncope  1  2/405 (0.49%)  2
Transient ischaemic attack  1  1/405 (0.25%)  1
Psychiatric disorders   
Substance use disorder  1  1/405 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  5/405 (1.23%)  6
Chronic obstructive pulmonary disease  1  22/405 (5.43%)  24
Dyspnoea  1  1/405 (0.25%)  1
1
Term from vocabulary, MedDRA v20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABS eMDPI
Affected / at Risk (%) # Events
Total   94/405 (23.21%)    
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  94/405 (23.21%)  104
1
Term from vocabulary, MedDRA v20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT03256695     History of Changes
Other Study ID Numbers: ABS-COPD-30065
First Submitted: August 18, 2017
First Posted: August 22, 2017
Results First Submitted: June 4, 2019
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019