Trial Outcomes & Findings for A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD (NCT NCT03573817)
NCT ID: NCT03573817
Last Updated: 2022-02-24
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Results posted on
2022-02-24
Participant Flow
Participants were randomized 1:1 to one of two treatment groups and received treatment twice-daily for the two 21-day treatment periods. The participants in Arms 1 and 2 are the same (minus attrition), and the participants in Arms 3 and 4 are the same (minus attrition).
Participant milestones
| Measure |
Revefenacin + Formoterol
Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42).
|
Placebo + Formoterol
Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42).
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
59
|
|
Overall Study
Randomized and Treated With Study Drug
|
63
|
59
|
|
Overall Study
COMPLETED
|
62
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Revefenacin + Formoterol
Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42).
|
Placebo + Formoterol
Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Baseline characteristics by cohort
| Measure |
Revefenacin + Formoterol
n=63 Participants
Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42).
|
Placebo + Formoterol
n=59 Participants
Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42).
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
116 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
|
63 participants
n=5 Participants
|
59 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Body Mass Index
|
29.22 kg/m^2
STANDARD_DEVIATION 6.642 • n=5 Participants
|
29.11 kg/m^2
STANDARD_DEVIATION 6.349 • n=7 Participants
|
29.17 kg/m^2
STANDARD_DEVIATION 6.475 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)Population: The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Outcome measures
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=59 Participants
Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=55 Participants
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=63 Participants
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=62 Participants
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)Population: The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe * Inpatient hospitalization or prolongation of existing hospitalization * Congenital anomaly in the offspring of a participant who received study drug * Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Outcome measures
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=59 Participants
Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=55 Participants
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=63 Participants
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=62 Participants
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)Population: The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Outcome measures
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=59 Participants
Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=55 Participants
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=63 Participants
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=62 Participants
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)Population: The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Outcome measures
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=59 Participants
Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=55 Participants
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=63 Participants
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=62 Participants
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)Population: The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.
Clinically relevant changes identified based on change from baseline.
Outcome measures
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=59 Participants
Days 1 to 21: revefenacin and formoterol sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=55 Participants
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=63 Participants
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=62 Participants
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Period 1: Revefenacin + Formoterol (Sequential)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2: Revefenacin + Formoterol (Combo Solution)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 1: Placebo + Formoterol (Sequential)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2: Placebo + Formoterol (Combo Solution)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Revefenacin + Formoterol (Sequential)
n=63 participants at risk；n=59 participants at risk
Days 1 to 21: Revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Revefenacin + Formoterol (Combo Solution)
n=62 participants at risk；n=55 participants at risk
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
Period 1: Placebo + Formoterol (Sequential)
n=59 participants at risk；n=63 participants at risk
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
|
Period 2: Placebo + Formoterol (Combo Solution)
n=55 participants at risk；n=62 participants at risk
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening.
|
|---|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.7%
1/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.8%
1/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
3.4%
2/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
3.6%
2/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.8%
1/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Tooth infection
|
1.6%
1/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Oral discomfort
|
1.6%
1/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.8%
1/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
3.4%
2/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.7%
1/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.7%
1/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.8%
1/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.7%
1/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.7%
1/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.6%
1/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/63 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/62 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/59 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
1.8%
1/55 • Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
|
Additional Information
Head of Clinical Development & Medical Affairs
Theravance Biopharma
Phone: 1-855-633-8479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER