Trial Outcomes & Findings for Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD (NCT NCT03095456)
NCT ID: NCT03095456
Last Updated: 2022-02-24
Results Overview
FEV1 = forced expiratory volume at one second
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2022-02-24
Participant Flow
Participant milestones
| Measure |
Revefenacin
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
104
|
|
Overall Study
COMPLETED
|
99
|
96
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Baseline characteristics by cohort
| Measure |
Revefenacin
n=102 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=104 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 7.94 • n=99 Participants
|
65.1 years
STANDARD_DEVIATION 8.36 • n=107 Participants
|
65.1 years
STANDARD_DEVIATION 8.13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
102 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Smoking history
Current Smoker
|
46 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Smoking history
Former Smoker
|
56 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: Intent-to-treat (ITT) analysis set
FEV1 = forced expiratory volume at one second
Outcome measures
| Measure |
Revefenacin
n=89 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=90 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 29
|
63.0 mL
Standard Error 20.17
|
47.3 mL
Standard Error 19.06
|
SECONDARY outcome
Timeframe: Baseline and Day 29Outcome measures
| Measure |
Revefenacin
n=89 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=90 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29
|
125.4 mL
Standard Error 38.75
|
55.8 mL
Standard Error 36.62
|
SECONDARY outcome
Timeframe: Baseline and Day 29Outcome measures
| Measure |
Revefenacin
n=82 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=88 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Change From Baseline Trough Inspiratory Capacity (IC) on Day 29
|
71.4 mL
Standard Error 42.33
|
84.1 mL
Standard Error 40.02
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (0-4 hours)Outcome measures
| Measure |
Revefenacin
n=91 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=90 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Change From Baseline Peak FEV1 on Day 29
|
174.2 mL
Standard Error 18.70
|
197.7 mL
Standard Error 17.73
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (0-4 hours)Outcome measures
| Measure |
Revefenacin
n=91 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=90 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Change From Baseline Peak FVC on Day 29
|
354.2 mL
Standard Error 37.35
|
340.1 mL
Standard Error 35.49
|
SECONDARY outcome
Timeframe: 1 MonthOutcome measures
| Measure |
Revefenacin
n=101 Participants
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=95 Participants
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Summary of Rescue Medication Use: Puffs Per Day
|
3.4 puffs per day
Standard Error 0.42
|
2.9 puffs per day
Standard Error 0.41
|
Adverse Events
Revefenacin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Spiriva Handihaler®
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revefenacin
n=103 participants at risk
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=104 participants at risk
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/103 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
0.96%
1/104 • Number of events 1 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
Other adverse events
| Measure |
Revefenacin
n=103 participants at risk
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin: Revefenacin administered via nebulization.
Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
|
Spiriva Handihaler®
n=104 participants at risk
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.97%
1/103 • Number of events 1 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
4.8%
5/104 • Number of events 5 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.97%
1/103 • Number of events 1 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
3.8%
4/104 • Number of events 4 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
2/103 • Number of events 2 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
2.9%
3/104 • Number of events 3 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/103 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
3.8%
4/104 • Number of events 4 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/103 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
3.8%
4/104 • Number of events 4 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
2/103 • Number of events 2 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
0.96%
1/104 • Number of events 1 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/103 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
2.9%
3/104 • Number of events 3 • From signing of ICF through the final follow-up assessment (approximately 1 month).
|
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