Trial Outcomes & Findings for Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI) (NCT NCT01857323)
NCT ID: NCT01857323
Last Updated: 2015-06-08
Results Overview
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.
COMPLETED
PHASE3
317 participants
Day 1 - Day 50
2015-06-08
Participant Flow
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.
Participant milestones
| Measure |
Albuterol Spiromax®
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 Study
STARTED
|
317
|
|
Overall Study
Safety Population
|
316
|
|
Overall Study
COMPLETED
|
253
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Albuterol Spiromax®
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 Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
4
|
|
Overall Study
Did not complete 180 doses
|
48
|
Baseline Characteristics
Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
Baseline characteristics by cohort
| Measure |
Albuterol Spiromax®
n=317 Participants
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.
|
|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 22.7 • n=5 Participants
|
|
Age, Customized
4-11 years
|
44 participants
n=5 Participants
|
|
Age, Customized
12-64 years
|
144 participants
n=5 Participants
|
|
Age, Customized
65+ years
|
129 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
268 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, non-Latino
|
292 participants
n=5 Participants
|
|
Disease Type
Asthma
|
167 participants
n=5 Participants
|
|
Disease Type
COPD
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 50Population: 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.
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=49454 Total # of dose cycles
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.
|
|---|---|
|
Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count
|
2.05 discrepancies/200 dose cycles
|
SECONDARY outcome
Timeframe: Day 1 - Day 50Population: 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.
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=49454 Total # of dose cycles
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.
|
|---|---|
|
Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up
|
2.46 discrepancies/200 dose cycles
|
SECONDARY outcome
Timeframe: Day 1 - Day 50Population: 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.
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=49454 Total # of dose cycles
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.
|
|---|---|
|
Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle
|
0.43 discrepancies/200 dose cycles
|
SECONDARY outcome
Timeframe: Day 1 - Day 50Population: 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.
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=49454 Total # of dose cycles
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.
|
|---|---|
|
Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle
|
0.17 discrepancies/200 dose cycles
|
SECONDARY outcome
Timeframe: Day 1 - Day 50Population: 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.
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=253 Participants
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.
|
|---|---|
|
Absolute Value of Total Discrepancy Size Per Inhaler
|
2.0 discrepancies/inhaler
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Day 1 to Day 50Population: Safety population
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.
Outcome measures
| Measure |
Albuterol Spiromax®
n=316 Participants
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.
|
|---|---|
|
Participants With Treatment-Emergent Adverse Events
Any adverse event
|
85 participants
|
|
Participants With Treatment-Emergent Adverse Events
Severe adverse event
|
2 participants
|
|
Participants With Treatment-Emergent Adverse Events
Treatment-related adverse event
|
7 participants
|
|
Participants With Treatment-Emergent Adverse Events
Deaths
|
0 participants
|
|
Participants With Treatment-Emergent Adverse Events
Other serious adverse events
|
2 participants
|
|
Participants With Treatment-Emergent Adverse Events
Withdrawn from study due to adverse event
|
1 participants
|
Adverse Events
Albuterol Spiromax®
Serious adverse events
| Measure |
Albuterol Spiromax®
n=316 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/316 • Number of events 1 • Day 1 to Day 50
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.32%
1/316 • Number of events 1 • Day 1 to Day 50
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.32%
1/316 • Number of events 1 • Day 1 to Day 50
|
Other adverse events
| Measure |
Albuterol Spiromax®
n=316 participants at risk
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.
|
|---|---|
|
Infections and infestations
Sinusitis
|
2.2%
7/316 • Number of events 7 • Day 1 to Day 50
|
|
Nervous system disorders
Headache
|
2.5%
8/316 • Number of events 10 • Day 1 to Day 50
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
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