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Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)

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ClinicalTrials.gov Identifier: NCT01857323
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Intervention Drug: Albuterol Spiromax®
Enrollment 317
Recruitment Details  
Pre-assignment Details Of the 28 screened patients who were not enrolled, 12 were excluded on the basis of inclusion criteria, 7 patients for exclusion criteria, 4 patients withdrew consent,1 patient was non-compliant, and 4 patients withdrew for other reasons before the baseline visit.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Period Title: Overall Study
Started 317 [1]
Safety Population 316 [2]
Completed 253
Not Completed 64
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             3
Non-compliance             1
Protocol Violation             6
Lost to Follow-up             1
Not specified             4
Did not complete 180 doses             48
[1]
36 day treatment cohort: 45 participants 50 day treatment cohort: 272 participants
[2]
One enrolled participant was lost to follow-up.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Baseline Participants 317
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 317 participants
51.3  (22.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 317 participants
4-11 years 44
12-64 years 144
65+ years 129
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants
Female
178
  56.2%
Male
139
  43.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 317 participants
White 268
Black 35
Asian 7
American Indian or Alaskan Native 1
Pacific Islander 1
Other, not specified 5
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 317 participants
Hispanic or Latino 25
Non-Hispanic, non-Latino 292
Disease Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 317 participants
Asthma 167
COPD 150
[1]
Measure Description: COPD = Chronic obstructive pulmonary disease
1.Primary Outcome
Title Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count
Hide Description The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.
Time Frame Day 1 - Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 253
Overall Number of Units Analyzed
Type of Units Analyzed: Total # of dose cycles
49454
Measure Type: Number
Unit of Measure: discrepancies/200 dose cycles
2.05
2.Secondary Outcome
Title Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up
Hide Description The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.
Time Frame Day 1 - Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 253
Overall Number of Units Analyzed
Type of Units Analyzed: Total # of dose cycles
49454
Measure Type: Number
Unit of Measure: discrepancies/200 dose cycles
2.46
3.Secondary Outcome
Title Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle
Hide Description The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.
Time Frame Day 1 - Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 253
Overall Number of Units Analyzed
Type of Units Analyzed: Total # of dose cycles
49454
Measure Type: Number
Unit of Measure: discrepancies/200 dose cycles
0.43
4.Secondary Outcome
Title Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle
Hide Description The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.
Time Frame Day 1 - Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 253
Overall Number of Units Analyzed
Type of Units Analyzed: Total # of dose cycles
49454
Measure Type: Number
Unit of Measure: discrepancies/200 dose cycles
0.17
5.Secondary Outcome
Title Absolute Value of Total Discrepancy Size Per Inhaler
Hide Description The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as “beginning counter reading minus end counter reading” minus “patient-recorded number of dose cycles". The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses.
Time Frame Day 1 - Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 253
Mean (Standard Deviation)
Unit of Measure: discrepancies/inhaler
2.0  (2.88)
6.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide Description 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.
Time Frame Day 1 to Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description:
The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Overall Number of Participants Analyzed 316
Measure Type: Number
Unit of Measure: participants
Any adverse event 85
Severe adverse event 2
Treatment-related adverse event 7
Deaths 0
Other serious adverse events 2
Withdrawn from study due to adverse event 1
Time Frame Day 1 to Day 50
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Spiromax®
Hide Arm/Group Description The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
All-Cause Mortality
Albuterol Spiromax®
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Spiromax®
Affected / at Risk (%) # Events
Total   2/316 (0.63%)    
Cardiac disorders   
Atrial fibrillation  1  1/316 (0.32%)  1
Supraventricular tachycardia  1  1/316 (0.32%)  1
Skin and subcutaneous tissue disorders   
Drug eruption  1  1/316 (0.32%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Albuterol Spiromax®
Affected / at Risk (%) # Events
Total   15/316 (4.75%)    
Infections and infestations   
Sinusitis  1  7/316 (2.22%)  7
Nervous system disorders   
Headache  1  8/316 (2.53%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01857323     History of Changes
Other Study ID Numbers: ABS-AS-308
First Submitted: May 15, 2013
First Posted: May 20, 2013
Results First Submitted: May 19, 2015
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015