Trial Outcomes & Findings for Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects (NCT NCT00909779)
NCT ID: NCT00909779
Last Updated: 2013-11-11
Results Overview
COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
841 participants
Primary outcome timeframe
0-12 months
Results posted on
2013-11-11
Participant Flow
Participant milestones
| Measure |
Placebo Twice Daily
Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Arformoterol 15 Mcg Twice Daily
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
421
|
420
|
|
Overall Study
COMPLETED
|
211
|
255
|
|
Overall Study
NOT COMPLETED
|
210
|
165
|
Reasons for withdrawal
| Measure |
Placebo Twice Daily
Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Arformoterol 15 Mcg Twice Daily
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
|---|---|---|
|
Overall Study
Adverse Event
|
53
|
55
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
19
|
15
|
|
Overall Study
Physician Decision
|
8
|
2
|
|
Overall Study
Protocol Violation
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
116
|
80
|
|
Overall Study
Site Ceasing Operation
|
2
|
2
|
|
Overall Study
Medical Monitor Decision
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
1
|
|
Overall Study
Randomized in error
|
1
|
1
|
Baseline Characteristics
Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Baseline characteristics by cohort
| Measure |
Placebo Comparator: Placebo Twice Daily
n=421 Participants
Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Experimental: Arformoterol 15 Mcg Twice Daily
n=420 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Total
n=841 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
222 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
426 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
199 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
|
Age Continuous
|
63.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
178 participants
n=5 Participants
|
183 participants
n=7 Participants
|
361 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
243 participants
n=5 Participants
|
236 participants
n=7 Participants
|
479 participants
n=5 Participants
|
|
Sex/Gender, Customized
Undifferentiated
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
402 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
813 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
374 Participants
n=5 Participants
|
372 Participants
n=7 Participants
|
746 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
421 participants
n=5 Participants
|
420 participants
n=7 Participants
|
841 participants
n=5 Participants
|
|
Number of COPD exacerbations in last year
|
0.8 Number of occurrences
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.0 Number of occurrences
STANDARD_DEVIATION 1.4 • n=7 Participants
|
0.9 Number of occurrences
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
FEV1
|
1.178 Liter
STANDARD_DEVIATION 0.487 • n=5 Participants
|
1.176 Liter
STANDARD_DEVIATION 0.482 • n=7 Participants
|
1.177 Liter
STANDARD_DEVIATION 0.485 • n=5 Participants
|
|
Percent predicted FEV1 (%)
|
39.4 Percentage (%)
STANDARD_DEVIATION 13.9 • n=5 Participants
|
39.7 Percentage (%)
STANDARD_DEVIATION 13.2 • n=7 Participants
|
39.5 Percentage (%)
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Baseline smoking status
Current
|
218 Current
n=5 Participants
|
214 Current
n=7 Participants
|
432 Current
n=5 Participants
|
|
Baseline smoking status
Former
|
203 Current
n=5 Participants
|
206 Current
n=7 Participants
|
409 Current
n=5 Participants
|
|
Number of pack-years smoked
≥ 15 - < 25
|
41 Pack-years
9.7 • n=5 Participants
|
40 Pack-years
9.5 • n=7 Participants
|
81 Pack-years
9.6 • n=5 Participants
|
|
Number of pack-years smoked
≥ 25 - < 30
|
36 Pack-years
8.6 • n=5 Participants
|
29 Pack-years
6.9 • n=7 Participants
|
65 Pack-years
7.7 • n=5 Participants
|
|
Number of pack-years smoked
≥ 30
|
344 Pack-years
81.7 • n=5 Participants
|
351 Pack-years
83.6 • n=7 Participants
|
695 Pack-years
82.6 • n=5 Participants
|
|
Baseline Oral/Inhaled Corticosteroid Use
No
|
202 participants
48.0 • n=5 Participants
|
202 participants
48.1 • n=7 Participants
|
404 participants
48.0 • n=5 Participants
|
|
Baseline Oral/Inhaled Corticosteroid Use
Yes
|
219 participants
52.0 • n=5 Participants
|
218 participants
51.9 • n=7 Participants
|
437 participants
52.0 • n=5 Participants
|
|
Baseline Oxygen Therapy Use
No
|
330 participants
78.4 • n=5 Participants
|
334 participants
79.5 • n=7 Participants
|
664 participants
79.0 • n=5 Participants
|
|
Baseline Oxygen Therapy Use
Yes
|
91 participants
21.6 • n=5 Participants
|
86 participants
20.5 • n=7 Participants
|
177 participants
21.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsPopulation: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit \> 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=63 Subjects with Primary Event
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=40 Subjects with Primary Event
Placebo twice daily
|
|---|---|---|
|
Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).
|
155.0 Days
Standard Deviation 91.2 • Interval 0.425 to 0.864
|
171.7 Days
Standard Deviation 98.7
|
SECONDARY outcome
Timeframe: 0-12 monthsPopulation: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
The Incidence of Protocol Defined COPD Exacerbations.
Overall
|
132 participants
|
122 participants
|
|
The Incidence of Protocol Defined COPD Exacerbations.
1 COPD event
|
72 participants
|
71 participants
|
|
The Incidence of Protocol Defined COPD Exacerbations.
2 COPD events
|
34 participants
|
29 participants
|
|
The Incidence of Protocol Defined COPD Exacerbations.
3 or more COPD events
|
26 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 0-12 monthsPopulation: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
The Incidence of All Cause Mortality
|
10 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 0-12 monthsPopulation: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date. The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
The Incidence of Treatment Emergent AEs
|
287 participants
|
306 participants
|
SECONDARY outcome
Timeframe: Baseline and on treatment at months 3, 6 and 12 (or early termination)Population: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
SGRQ: Mean Change From Baseline in Total Score
Month 3 (n=276,308)
|
-1.544 Score
Standard Error 0.609
|
-3.876 Score
Standard Error 0.575
|
|
SGRQ: Mean Change From Baseline in Total Score
Month 6 (n=233,287)
|
-1.855 Score
Standard Error 0.746
|
-4.054 Score
Standard Error 0.679
|
|
SGRQ: Mean Change From Baseline in Total Score
Month 12 (n=199,236)
|
-2.673 Score
Standard Error 0.800
|
-4.796 Score
Standard Error 0.735
|
|
SGRQ: Mean Change From Baseline in Total Score
EOS (n=375,379)
|
-0.587 Score
Standard Error 0.616
|
-3.231 Score
Standard Error 0.613
|
SECONDARY outcome
Timeframe: Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)Population: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
FEV1: Mean Change From Baseline
Month 6 (n=248,300)
|
0.036 Liter
Standard Error 0.023
|
0.090 Liter
Standard Error 0.021
|
|
FEV1: Mean Change From Baseline
Month 3 (n=289,331)
|
0.027 Liter
Standard Error 0.018
|
0.093 Liter
Standard Error 0.016
|
|
FEV1: Mean Change From Baseline
Month 9 (n=223,268)
|
0.048 Liter
Standard Error 0.019
|
0.092 Liter
Standard Error 0.018
|
|
FEV1: Mean Change From Baseline
Month 12 (n=206,253)
|
0.020 Liter
Standard Error 0.020
|
0.059 Liter
Standard Error 0.018
|
|
FEV1: Mean Change From Baseline
EOS (n=380,391)
|
0.047 Liter
Standard Error 0.016
|
0.072 Liter
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)Population: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
Percent Predicted FEV1: Mean Change From Baseline
Month 3 (n=289,331)
|
1.410 Liter
Standard Error 0.533
|
3.480 Liter
Standard Error 0.498
|
|
Percent Predicted FEV1: Mean Change From Baseline
Month 6 (n=248,300)
|
1.768 Liter
Standard Error 0.648
|
3.460 Liter
Standard Error 0.594
|
|
Percent Predicted FEV1: Mean Change From Baseline
Month 9 (n=223,268)
|
2.606 Liter
Standard Error 0.626
|
3.651 Liter
Standard Error 0.576
|
|
Percent Predicted FEV1: Mean Change From Baseline
Month 12 (n=206,252)
|
1.678 Liter
Standard Error 0.642
|
2.662 Liter
Standard Error 0.586
|
|
Percent Predicted FEV1: Mean Change From Baseline
EOS (n=380,391)
|
2.156 Liter
Standard Error 0.493
|
2.936 Liter
Standard Error 0.486
|
SECONDARY outcome
Timeframe: Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)Population: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
Forced Vital Capacity (FVC): Mean Change From Baseline
EOS (n=380,391)
|
0.056 Liter
Standard Error 0.022
|
0.102 Liter
Standard Error 0.022
|
|
Forced Vital Capacity (FVC): Mean Change From Baseline
Month 3 (n=289,331)
|
0.039 Liter
Standard Error 0.024
|
0.139 Liter
Standard Error 0.022
|
|
Forced Vital Capacity (FVC): Mean Change From Baseline
Month 6 (n=248,300)
|
0.056 Liter
Standard Error 0.031
|
0.120 Liter
Standard Error 0.028
|
|
Forced Vital Capacity (FVC): Mean Change From Baseline
Month 9 (n=223,268)
|
0.049 Liter
Standard Error 0.029
|
0.139 Liter
Standard Error 0.027
|
|
Forced Vital Capacity (FVC): Mean Change From Baseline
Month 12 (n=206,253)
|
0.040 Liter
Standard Error 0.029
|
0.088 Liter
Standard Error 0.027
|
SECONDARY outcome
Timeframe: Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)Population: Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.
IC: the total amount of air that can be drawn into the lungs after normal expiration. IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline.
Outcome measures
| Measure |
Experimental: Arformoterol 15 Mcg Twice Daily
n=421 Participants
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Placebo
n=420 Participants
Placebo twice daily
|
|---|---|---|
|
Inspiratory Capacity (IC): Mean Change From Baseline
EOS (n=374,384)
|
0.031 Liter
Standard Error 0.022
|
0.058 Liter
Standard Error 0.021
|
|
Inspiratory Capacity (IC): Mean Change From Baseline
Month 3 (n=284,320)
|
0.030 Liter
Standard Error 0.023
|
0.054 Liter
Standard Error 0.021
|
|
Inspiratory Capacity (IC): Mean Change From Baseline
Month 6 (n=243,298)
|
-0.011 Liter
Standard Error 0.026
|
0.067 Liter
Standard Error 0.024
|
|
Inspiratory Capacity (IC): Mean Change From Baseline
Month 9 (n=218,258)
|
0.046 Liter
Standard Error 0.029
|
0.096 Liter
Standard Error 0.027
|
|
Inspiratory Capacity (IC): Mean Change From Baseline
Month 12 (n=199,246)
|
0.004 Liter
Standard Error 0.029
|
0.035 Liter
Standard Error 0.027
|
Adverse Events
Placebo Comparator: Placebo Twice Daily
Serious events: 95 serious events
Other events: 180 other events
Deaths: 0 deaths
Experimental: Arformoterol 15 Mcg Twice Daily
Serious events: 86 serious events
Other events: 174 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Comparator: Placebo Twice Daily
n=421 participants at risk
Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Experimental: Arformoterol 15 Mcg Twice Daily
n=420 participants at risk
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.71%
3/420 • Number of events 3 • 1 year
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.71%
3/420 • Number of events 3 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Cardiac disorders
Bundle branch block right
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.71%
3/421 • Number of events 3 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/421 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Cardiac disorders
Corpulmonale
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/421 • 1 year
|
0.71%
3/420 • Number of events 3 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 2 • 1 year
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Eye disorders
Retinal artery occlusion
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colonic polyp
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.71%
3/420 • Number of events 3 • 1 year
|
|
General disorders
Oedema peripheral
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Abscess limb
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Bronchitis
|
2.1%
9/421 • Number of events 10 • 1 year
|
0.71%
3/420 • Number of events 4 • 1 year
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Gastritis fungal
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Gastroenteritis bacteria
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Influenza
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomy
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Peridiverticular abscess
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Pneumonia
|
3.3%
14/421 • Number of events 18 • 1 year
|
2.9%
12/420 • Number of events 13 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/421 • 1 year
|
0.71%
3/420 • Number of events 3 • 1 year
|
|
Infections and infestations
Septic shock
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.24%
1/421 • Number of events 4 • 1 year
|
0.00%
0/420 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Investigations
Blood phosphorus decreased
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.00%
0/420 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.24%
1/421 • Number of events 2 • 1 year
|
0.00%
0/420 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.00%
0/420 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Altered state of consciousness
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Nervous system disorders
Ataxia
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Affective disorder
|
0.24%
1/421 • Number of events 4 • 1 year
|
0.00%
0/420 • 1 year
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Psychiatric disorders
Depression
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Major depression
|
0.00%
0/421 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urethral obstruction
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.95%
4/421 • Number of events 5 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
13.1%
55/421 • Number of events 76 • 1 year
|
8.3%
35/420 • Number of events 44 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.48%
2/421 • Number of events 3 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.48%
2/421 • Number of events 2 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
2/421 • Number of events 3 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertensive emergency
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/421 • 1 year
|
0.48%
2/420 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/421 • 1 year
|
0.24%
1/420 • Number of events 1 • 1 year
|
|
Investigations
C-reactive protein increased
|
0.24%
1/421 • Number of events 1 • 1 year
|
0.00%
0/420 • 1 year
|
Other adverse events
| Measure |
Placebo Comparator: Placebo Twice Daily
n=421 participants at risk
Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
Experimental: Arformoterol 15 Mcg Twice Daily
n=420 participants at risk
Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.7%
28/421 • Number of events 36 • 1 year
|
10.2%
43/420 • Number of events 58 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
33/421 • Number of events 49 • 1 year
|
9.0%
38/420 • Number of events 50 • 1 year
|
|
Infections and infestations
Sinusitis
|
5.2%
22/421 • Number of events 29 • 1 year
|
4.5%
19/420 • Number of events 27 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
22/421 • Number of events 26 • 1 year
|
5.2%
22/420 • Number of events 28 • 1 year
|
|
Nervous system disorders
Headache
|
5.0%
21/421 • Number of events 39 • 1 year
|
8.3%
35/420 • Number of events 53 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
19.7%
83/421 • Number of events 122 • 1 year
|
17.9%
75/420 • Number of events 115 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
30/421 • Number of events 46 • 1 year
|
5.7%
24/420 • Number of events 27 • 1 year
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER