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A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-5)

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: NCT02276222
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer
Drug: Spiriva® 18 mcg QD Handihaler
Enrollment 1087
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Period Title: Overall Study
Started 621 466
Completed 436 [1] 402
Not Completed 185 64
Reason Not Completed
Adverse Event             62             11
Death             3             4
Lack of Efficacy             13             3
Protocol Violation             3             2
Withdrawal by Subject             79             33
non compliance with study medication             6             2
sponsor decision             0             3
Lost to Follow-up             15             5
Physician Decision             2             1
sheduling conflict             1             0
subject withdrew after randomization             1             0
[1]
one subject withdrew at randomization due to a pre-treatment event prior to being dosed
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler Total
Hide Arm/Group Description

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Total of all reporting groups
Overall Number of Baseline Participants 620 466 1086
Hide Baseline Analysis Population Description
As noted in the participant flow section, one subject withdrew at randomization due to a pre-treatment event prior to being dosed bringing the population total to 1086 from 1087.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
330
  53.2%
256
  54.9%
586
  54.0%
>=65 years
290
  46.8%
210
  45.1%
500
  46.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 620 participants 466 participants 1086 participants
63.3  (8.46) 63.3  (8.97) 63.3  (8.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
Female
270
  43.5%
206
  44.2%
476
  43.8%
Male
350
  56.5%
260
  55.8%
610
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
Hispanic or Latino
9
   1.5%
9
   1.9%
18
   1.7%
Not Hispanic or Latino
611
  98.5%
457
  98.1%
1068
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
American Indian or Alaska Native
2
   0.3%
2
   0.4%
4
   0.4%
Asian
1
   0.2%
1
   0.2%
2
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
35
   5.6%
27
   5.8%
62
   5.7%
White
582
  93.9%
436
  93.6%
1018
  93.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
Russia 25 21 46
Czechia 5 4 9
Hungary 34 20 54
United States 556 421 977
cardiovascular risk (low/high) and categories for high cardiovascular risk  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
low cardiovascular risk 219 169 388
high cardiovascular risk 401 297 698
ischemic heart disease 61 44 105
cerebrovascular disease 28 18 46
periheral arterial disease 39 24 63
clinically significant arrhythmia 22 14 36
heart failure 23 9 32
hyertension 362 275 637
background long-acting beta (2) agonist (LABA) use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 620 participants 466 participants 1086 participants
background LABA use -yes 267 192 459
background LABA use -no 353 274 627
Forced expiratory volume in one second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 620 participants 466 participants 1086 participants
1.3399  (0.49604) 1.3257  (0.50186) 1.3365  (0.51414)
1.Primary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events (TEAE)
Hide Description A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: participants
430 312
2.Primary Outcome
Title Percentage of Subjects With Treatment-emergent Adverse Events
Hide Description A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: percentage of participants
69.4 67.0
3.Primary Outcome
Title Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)
Hide Description A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: participants
76 49
4.Primary Outcome
Title Percentage of Subjects With Treatment-emergent Serious Adverse
Hide Description A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: percentage of participants
12.3 10.5
5.Primary Outcome
Title Number of Subjects Who Discontinue the Study Due to TEAE
Hide Description A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: participants
62 13
6.Primary Outcome
Title Percentage of Subjects Who Discontinue the Study Due to TEAE
Hide Description A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: percentage of participants
10.0 2.8
7.Secondary Outcome
Title Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
Hide Description All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: participants
MACE score 3 8
cardiovascular death 1 2
non-fatal myocardial infarction 2 5
non-fatal stroke 0 1
8.Secondary Outcome
Title Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
Hide Description All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: percentage of participants
MACE score 0.5 1.7
cardiovascular death 0.2 0.4
non-fatal myocardial infarction 0.3 1.1
non-fatal stroke 0 0.2
9.Secondary Outcome
Title Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
Hide Description All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
Time Frame up to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Measure Type: Number
Unit of Measure: event per 1000 person years
MACE score 6.4 20.3
cardiovascular death 2.1 5.1
non-fatal myocardial infarction 4.3 12.7
non-fatal stroke 0 2.5
10.Secondary Outcome
Title Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects
Hide Description

Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment.

Values affected by other medication use were to be set to missing.

Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description:

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Overall Number of Participants Analyzed 620 466
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1016  (0.00698) 0.0931  (0.00779)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SUN-101 50 mcg BID eFlow (CS) Nebulizer, Spiriva 18 mcg QD Handihaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4041
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.0084
Confidence Interval (2-Sided) 95%
-0.0114 to 0.0283
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01012
Estimation Comments [Not Specified]
Time Frame up to week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Hide Arm/Group Description

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

All-Cause Mortality
SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Affected / at Risk (%) Affected / at Risk (%)
Total   3/620 (0.48%)      4/466 (0.86%)    
Show Serious Adverse Events Hide Serious Adverse Events
SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/620 (12.26%)      49/466 (10.52%)    
Cardiac disorders     
acute myocardial infarction  1  1/620 (0.16%)  1 1/466 (0.21%)  1
angina pectoris  1  0/620 (0.00%)  0 1/466 (0.21%)  1
atrial fibrillation  1  2/620 (0.32%)  2 1/466 (0.21%)  1
arterial flutter  1  1/620 (0.16%)  1 0/466 (0.00%)  0
cardiac failure congestive  1  1/620 (0.16%)  1 2/466 (0.43%)  2
cardio respiratory arrest  1  3/620 (0.48%)  3 1/466 (0.21%)  1
coronary artery disease  1  3/620 (0.48%)  3 0/466 (0.00%)  0
myocardial infraction  1  1/620 (0.16%)  1 1/466 (0.21%)  1
verntricular arrhythmia  1  1/620 (0.16%)  1 1/466 (0.21%)  1
Eye disorders     
diplopia  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Gastrointestinal disorders     
abdominal pain  1  1/620 (0.16%)  1 1/466 (0.21%)  1
colitis  1  1/620 (0.16%)  1 0/466 (0.00%)  0
constipation  1  1/620 (0.16%)  1 0/466 (0.00%)  0
duodenal ulcer, obstructive  1  0/620 (0.00%)  0 1/466 (0.21%)  1
gastric ulcer haemorrhage  1  0/620 (0.00%)  0 1/466 (0.21%)  1
gastric ulcer perforation  1  1/620 (0.16%)  1 0/466 (0.00%)  0
gastrointestinal perforation  1  0/620 (0.00%)  0 1/466 (0.21%)  1
gastrooesophageal reflux disease  1  2/620 (0.32%)  2 0/466 (0.00%)  0
haematochezia  1  0/620 (0.00%)  0 1/466 (0.21%)  1
large intestinal obstruction  1  0/620 (0.00%)  0 1/466 (0.21%)  1
pancreatitis  1  1/620 (0.16%)  1 0/466 (0.00%)  0
rectal haemorrhage  1  0/620 (0.00%)  0 1/466 (0.21%)  1
small intestinal obstruction  1  0/620 (0.00%)  0 1/466 (0.21%)  1
General disorders     
chest pain  1  1/620 (0.16%)  1 0/466 (0.00%)  0
generalized oedema  1  1/620 (0.16%)  1 0/466 (0.00%)  0
non-cardiac chest pain  1  1/620 (0.16%)  1 2/466 (0.43%)  2
pain  1  1/620 (0.16%)  1 0/466 (0.00%)  0
pyrexia  1  0/620 (0.00%)  0 1/466 (0.21%)  1
Hepatobiliary disorders     
cholecystitis  1  2/620 (0.32%)  2 0/466 (0.00%)  0
cholecystitis acute  1  1/620 (0.16%)  1 0/466 (0.00%)  0
choleithiasis  1  2/620 (0.32%)  2 0/466 (0.00%)  0
Infections and infestations     
abdominal infection  1  1/620 (0.16%)  1 0/466 (0.00%)  0
appendicitis  1  1/620 (0.16%)  1 1/466 (0.21%)  1
bronchitis  1  2/620 (0.32%)  2 1/466 (0.21%)  1
gastroenteritis  1  1/620 (0.16%)  1 0/466 (0.00%)  0
gastronenteritis viral  1  1/620 (0.16%)  1 0/466 (0.00%)  0
osteomyelitis  1  1/620 (0.16%)  1 0/466 (0.00%)  0
pheumonia  1  8/620 (1.29%)  8 3/466 (0.64%)  3
sepsis  1  0/620 (0.00%)  0 3/466 (0.64%)  3
septic shock  1  0/620 (0.00%)  0 1/466 (0.21%)  1
systemic candida  1  1/620 (0.16%)  1 0/466 (0.00%)  0
urinary tract infection  1  2/620 (0.32%)  2 1/466 (0.21%)  3
urosepsis  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Injury, poisoning and procedural complications     
accidental overdose  1  1/620 (0.16%)  1 0/466 (0.00%)  0
ankle fracture  1  1/620 (0.16%)  1 0/466 (0.00%)  0
hip fracture  1  3/620 (0.48%)  3 0/466 (0.00%)  0
impacted fracture  1  1/620 (0.16%)  1 0/466 (0.00%)  0
joint injury  1  0/620 (0.00%)  0 1/466 (0.21%)  1
pubis fracture  1  1/620 (0.16%)  1 0/466 (0.00%)  0
road traffic accident  1  1/620 (0.16%)  1 0/466 (0.00%)  0
subdural haematoma  1  0/620 (0.00%)  0 1/466 (0.21%)  1
vascular pseudoaneurysm  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Metabolism and nutrition disorders     
dehydration  1  1/620 (0.16%)  2 0/466 (0.00%)  0
hypokalaemia  1  1/620 (0.16%)  1 0/466 (0.00%)  0
malnutrition  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Musculoskeletal and connective tissue disorders     
back pain  1  1/620 (0.16%)  1 0/466 (0.00%)  0
joint effsion  1  0/620 (0.00%)  0 1/466 (0.21%)  1
osteoarthritis  1  1/620 (0.16%)  1 2/466 (0.43%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
benign lung neoplasm  1  1/620 (0.16%)  1 0/466 (0.00%)  0
bladder cancer  1  1/620 (0.16%)  1 1/466 (0.21%)  1
breast cancer  1  0/620 (0.00%)  0 1/466 (0.21%)  1
carcinoid tumor of the apendix  1  1/620 (0.16%)  1 0/466 (0.00%)  0
colon cancer  1  0/620 (0.00%)  0 1/466 (0.21%)  1
endometrial cancer  1  1/620 (0.16%)  1 0/466 (0.00%)  0
lung adenocarcinoma  1  0/620 (0.00%)  0 1/466 (0.21%)  1
meningioma  1  1/620 (0.16%)  1 0/466 (0.00%)  0
metastatic renal cell carcinoma  1  1/620 (0.16%)  1 0/466 (0.00%)  0
non-hodgkins lymphoma  1  1/620 (0.16%)  1 0/466 (0.00%)  0
pancreatic crcinoma  1  1/620 (0.16%)  1 0/466 (0.00%)  0
prostate cancer  1  1/620 (0.16%)  1 0/466 (0.00%)  0
rectal cancer  1  1/620 (0.16%)  1 0/466 (0.00%)  0
small cell lung cancer stage unspecified  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Nervous system disorders     
hashimoto's encephalopathy  1  1/620 (0.16%)  1 0/466 (0.00%)  0
lumbar radiculopathy  1  0/620 (0.00%)  0 1/466 (0.21%)  1
multile sclerosis relapse  1  0/620 (0.00%)  0 1/466 (0.21%)  1
serotonin syndrome  1  1/620 (0.16%)  1 0/466 (0.00%)  0
syncope  1  1/620 (0.16%)  1 0/466 (0.00%)  0
transient ischaemic attack  1  1/620 (0.16%)  1 0/466 (0.00%)  0
suicidal ideation  1  2/620 (0.32%)  2 0/466 (0.00%)  0
Psychiatric disorders     
anxiety  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Renal and urinary disorders     
renal failure  1  1/620 (0.16%)  1 0/466 (0.00%)  0
renal mass  1  1/620 (0.16%)  1 0/466 (0.00%)  0
urinary retention  1  0/620 (0.00%)  0 1/466 (0.21%)  1
Respiratory, thoracic and mediastinal disorders     
acute respiratory distress syndrome  1  1/620 (0.16%)  1 0/466 (0.00%)  0
acute respiratory failure  1  1/620 (0.16%)  1 0/466 (0.00%)  0
chronic obstructive pulmonary disease  1  17/620 (2.74%)  18 14/466 (3.00%)  15
dyspnoea  1  2/620 (0.32%)  2 0/466 (0.00%)  0
hypoxia  1  0/620 (0.00%)  0 1/466 (0.21%)  1
pleurisy  1  1/620 (0.16%)  1 0/466 (0.00%)  0
pneumonia aspiration  1  2/620 (0.32%)  2 0/466 (0.00%)  0
pneumothorax  1  3/620 (0.48%)  3 0/466 (0.00%)  0
pulmonary embolism  1  1/620 (0.16%)  1 2/466 (0.43%)  2
respiratory failure  1  1/620 (0.16%)  1 1/466 (0.21%)  1
pluritic pain  1  1/620 (0.16%)  1 0/466 (0.00%)  0
COPD exacerbation  1  0/620 (0.00%)  0 1/466 (0.21%)  1
Skin and subcutaneous tissue disorders     
angioedema  1  1/620 (0.16%)  1 0/466 (0.00%)  0
Vascular disorders     
aortic aneurysm  1  2/620 (0.32%)  2 1/466 (0.21%)  2
arterios clerosis  1  0/620 (0.00%)  0 1/466 (0.21%)  1
hypertension  1  1/620 (0.16%)  1 0/466 (0.00%)  0
1
Term from vocabulary, MedDRA 15.0
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%
SUN-101 50 mcg BID eFlow (CS) Nebulizer Spiriva 18 mcg QD Handihaler
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   195/620 (31.45%)      133/466 (28.54%)    
Infections and infestations     
nasopharyngitis  1  25/620 (4.03%)  31 28/466 (6.01%)  32
upper respiratory tract infection  1  38/620 (6.13%)  42 25/466 (5.36%)  28
Respiratory, thoracic and mediastinal disorders     
chronic obstructive pulmonary disease  1  91/620 (14.68%)  119 82/466 (17.60%)  107
cough  1  73/620 (11.77%)  78 26/466 (5.58%)  28
1
Term from vocabulary, MedDRA 15.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Layout table for additonal information
Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02276222     History of Changes
Other Study ID Numbers: SUN101-303
First Submitted: October 14, 2014
First Posted: October 28, 2014
Results First Submitted: January 2, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018