Trial Outcomes & Findings for PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD (NCT NCT01566773)
NCT ID: NCT01566773
Last Updated: 2017-10-12
Results Overview
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Results posted on
2017-10-12
Participant Flow
The study was conducted at 10 sites in the US from April 2012 to August 2012. Study participation maximum of 26 weeks.
A randomized, double-blind,chronic dosing, four-period, eight-treatment, placebo-controlled, incomplete block, crossover, multicenter study.
Participant milestones
| Measure |
All Subjects
|
|---|---|
|
Overall Study
STARTED
|
140
|
|
Overall Study
GP MDI 18 µg BID
|
64
|
|
Overall Study
GP MDI 9 µg BID
|
64
|
|
Overall Study
GP MDI 4.6 µg BID
|
62
|
|
Overall Study
GP MDI 2.4 µg BID
|
64
|
|
Overall Study
GP MDI 1.2 µg BID
|
57
|
|
Overall Study
GP MDI 0.6 µg BID
|
59
|
|
Overall Study
Placebo MDI
|
62
|
|
Overall Study
Spiriva® Handihaler®
|
62
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
All Subjects
|
|---|---|
|
Overall Study
Protocol specified criteria
|
4
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Administrative reason
|
1
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Baseline characteristics by cohort
| Measure |
All Subjects
n=140 Participants
All Subjects
|
|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)Population: MITT (Modified Intent to Treat) Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=53 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=52 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=55 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 AUC0-12
|
1.448 Liter
Interval 1.405 to 1.491
|
1.416 Liter
Interval 1.374 to 1.459
|
1.432 Liter
Interval 1.389 to 1.474
|
1.416 Liter
Interval 1.374 to 1.458
|
1.386 Liter
Interval 1.342 to 1.43
|
1.353 Liter
Interval 1.309 to 1.397
|
1.290 Liter
Interval 1.246 to 1.335
|
1.514 Liter
Interval 1.471 to 1.558
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Highest value of FEV1 post dose on day 1
Outcome measures
| Measure |
GP MDI 18 µg BID
n=59 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=60 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1
|
231 mL
Interval 191.0 to 272.0
|
226 mL
Interval 186.0 to 267.0
|
165 mL
Interval 125.0 to 205.0
|
170 mL
Interval 130.0 to 211.0
|
136 mL
Interval 95.0 to 177.0
|
107 mL
Interval 65.0 to 149.0
|
57 mL
Interval 17.0 to 97.0
|
270 mL
Interval 229.0 to 311.0
|
SECONDARY outcome
Timeframe: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Time to Onset of Action (\>10% Improvement in FEV1) on Day 1.
Outcome measures
| Measure |
GP MDI 18 µg BID
n=55 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=56 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=57 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=58 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=50 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=55 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=54 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
15 minutes
|
29 % of participants
|
30 % of participants
|
14 % of participants
|
21 % of participants
|
18 % of participants
|
7 % of participants
|
4 % of participants
|
39 % of participants
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
30 minutes
|
22 % of participants
|
11 % of participants
|
9 % of participants
|
16 % of participants
|
12 % of participants
|
9 % of participants
|
7 % of participants
|
15 % of participants
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
1 hour
|
26 % of participants
|
11 % of participants
|
11 % of participants
|
10 % of participants
|
10 % of participants
|
17 % of participants
|
9 % of participants
|
15 % of participants
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
2 hours
|
0 % of participants
|
16 % of participants
|
11 % of participants
|
7 % of participants
|
10 % of participants
|
7 % of participants
|
2 % of participants
|
11 % of participants
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
No onset within 2 hours
|
24 % of participants
|
32 % of participants
|
56 % of participants
|
47 % of participants
|
50 % of participants
|
59 % of participants
|
78 % of participants
|
20 % of participants
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Percentage of subjects achieving at least 12% improvement in FEV1.
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=56 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=58 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=52 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=56 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=56 Participants
Placebo MDI.
|
Spiriva® Handihaler®
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
|
70 Percentage of participants
|
59 Percentage of participants
|
40 Percentage of participants
|
47 Percentage of participants
|
40 Percentage of participants
|
31 Percentage of participants
|
71 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (1 hr and 2 hr post-dose )Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline
Outcome measures
| Measure |
GP MDI 18 µg BID
n=59 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=61 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=60 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in Inspiratory Capacity (IC)
|
234 mL
Interval 163.0 to 304.0
|
263 mL
Interval 193.0 to 333.0
|
151 mL
Interval 82.0 to 219.0
|
183 mL
Interval 113.0 to 252.0
|
126 mL
Interval 54.0 to 198.0
|
82 mL
Interval 9.0 to 155.0
|
80 mL
Interval 10.0 to 150.0
|
343 mL
Interval 271.0 to 414.0
|
SECONDARY outcome
Timeframe: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1
|
88 mL
Interval 48.0 to 128.0
|
90 mL
Interval 50.0 to 129.0
|
109 mL
Interval 70.0 to 149.0
|
96 mL
Interval 57.0 to 135.0
|
43 mL
Interval 2.0 to 84.0
|
23 mL
Interval -18.0 to 64.0
|
10 mL
Interval -29.0 to 50.0
|
156 mL
Interval 116.0 to 196.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1
|
286 mL
Interval 239.0 to 333.0
|
269 mL
Interval 223.0 to 316.0
|
266 mL
Interval 220.0 to 313.0
|
235 mL
Interval 189.0 to 282.0
|
225 mL
Interval 178.0 to 273.0
|
166 mL
Interval 118.0 to 214.0
|
114 mL
Interval 67.0 to 161.0
|
366 mL
Interval 318.0 to 413.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
|
137 mL
Interval 75.0 to 198.0
|
57 mL
Interval -4.0 to 118.0
|
101 mL
Interval 40.0 to 162.0
|
142 mL
Interval 81.0 to 203.0
|
73 mL
Interval 10.0 to 137.0
|
54 mL
Interval -10.0 to 118.0
|
62 mL
Interval 1.0 to 124.0
|
184 mL
Interval 121.0 to 247.0
|
SECONDARY outcome
Timeframe: Day 7 (mean of 1 hr and 2 hr post-dose assessments)Population: MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.
Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in IC
|
302 mL
Interval 227.0 to 377.0
|
234 mL
Interval 160.0 to 309.0
|
254 mL
Interval 180.0 to 328.0
|
312 mL
Interval 238.0 to 386.0
|
195 mL
Interval 118.0 to 272.0
|
159 mL
Interval 82.0 to 236.0
|
99 mL
Interval 24.0 to 174.0
|
390 mL
Interval 314.0 to 466.0
|
SECONDARY outcome
Timeframe: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)Population: MITT Population
Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 \[Treatment Day 1\])
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=59 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Pre-dose Daily PEFR
|
8.0 L/min
Interval 1.1 to 15.0
|
3.2 L/min
Interval -3.7 to 10.2
|
0.2 L/min
Interval -6.7 to 7.1
|
2.4 L/min
Interval -4.5 to 9.3
|
-2.4 L/min
Interval -9.5 to 4.6
|
-2.5 L/min
Interval -9.5 to 4.6
|
-7.2 L/min
Interval -14.1 to -0.3
|
12.7 L/min
Interval 5.6 to 19.7
|
SECONDARY outcome
Timeframe: Day 7 (30 minutes post-dose)Population: MITT Population
Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 \[Treatment Day 1\])
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=59 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Post-dose Daily PEFR
|
32.3 L/min
Interval 24.8 to 39.8
|
23.9 L/min
Interval 16.5 to 31.4
|
17.2 L/min
Interval 9.8 to 24.6
|
18.3 L/min
Interval 10.8 to 25.7
|
14.3 L/min
Interval 6.6 to 21.9
|
13.7 L/min
Interval 6.0 to 21.3
|
4.5 L/min
Interval -2.9 to 12.0
|
38.0 L/min
Interval 30.4 to 45.6
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=59 Participants
Placebo MDI.
|
Spiriva® Handihaler®
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Pre-dose PEFR
|
15.8 L/min
Interval 8.6 to 22.9
|
12.6 L/min
Interval 5.6 to 19.6
|
4.7 L/min
Interval -2.3 to 11.7
|
11.2 L/min
Interval 4.2 to 18.3
|
7.5 L/min
Interval 0.2 to 14.7
|
5.9 L/min
Interval -1.3 to 13.1
|
3.3 L/min
Interval -3.8 to 10.4
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=59 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=55 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Post-dose PEFR
|
42.2 L/min
Interval 34.2 to 50.2
|
30.3 L/min
Interval 22.4 to 38.3
|
21.6 L/min
Interval 13.7 to 29.5
|
24.3 L/min
Interval 16.3 to 32.3
|
20.2 L/min
Interval 12.1 to 28.3
|
22.1 L/min
Interval 14.0 to 30.2
|
11.0 L/min
Interval 3.1 to 19.0
|
35.6 L/min
Interval 27.4 to 43.7
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Outcome measures
| Measure |
GP MDI 18 µg BID
n=59 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=61 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=60 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=58 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Number of Puffs of Rescue Medication
|
0.9 Puffs
Interval 0.6 to 1.37
|
1.3 Puffs
Interval 0.88 to 1.89
|
1.2 Puffs
Interval 0.85 to 1.71
|
1.2 Puffs
Interval 0.82 to 1.58
|
1.5 Puffs
Interval 1.03 to 1.99
|
1.6 Puffs
Interval 1.12 to 2.19
|
2.0 Puffs
Interval 1.46 to 2.66
|
0.9 Puffs
Interval 0.63 to 1.28
|
SECONDARY outcome
Timeframe: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)Population: MITT Population
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=56 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1
|
89 mL
Interval 47.0 to 132.0
|
80 mL
Interval 38.0 to 122.0
|
67 mL
Interval 26.0 to 109.0
|
77 mL
Interval 35.0 to 118.0
|
68 mL
Interval 25.0 to 111.0
|
29 mL
Interval -14.0 to 72.0
|
-8 mL
Interval -50.0 to 35.0
|
126 mL
Interval 84.0 to 168.0
|
SECONDARY outcome
Timeframe: Day 14Population: MITT Population
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=54 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=54 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1
|
288 mL
Interval 236.0 to 339.0
|
288 mL
Interval 237.0 to 340.0
|
287 mL
Interval 236.0 to 338.0
|
261 mL
Interval 210.0 to 312.0
|
246 mL
Interval 193.0 to 299.0
|
188 mL
Interval 135.0 to 241.0
|
130 mL
Interval 77.0 to 183.0
|
361 mL
Interval 309.0 to 413.0
|
SECONDARY outcome
Timeframe: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)Population: MITT Population
Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=56 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline for Mean Morning Pre-dose Trough IC
|
94 mL
Interval 32.0 to 156.0
|
45 mL
Interval -16.0 to 106.0
|
64 mL
Interval 3.0 to 124.0
|
104 mL
Interval 43.0 to 165.0
|
69 mL
Interval 6.0 to 132.0
|
34 mL
Interval -30.0 to 97.0
|
9 mL
Interval -54.0 to 71.0
|
138 mL
Interval 76.0 to 201.0
|
SECONDARY outcome
Timeframe: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)Population: MITT Population
Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=54 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=54 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=56 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in IC
|
280 mL
Interval 197.0 to 363.0
|
259 mL
Interval 177.0 to 341.0
|
288 mL
Interval 206.0 to 370.0
|
226 mL
Interval 145.0 to 308.0
|
261 mL
Interval 176.0 to 346.0
|
172 mL
Interval 87.0 to 256.0
|
77 mL
Interval -6.0 to 161.0
|
284 mL
Interval 200.0 to 368.0
|
SECONDARY outcome
Timeframe: Day 14 (Baseline, 11.5 and 12 hours post dose)Population: MITT Population
12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=53 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=54 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 12-hour Post-dose Trough FEV1
|
116 mL
Interval 69.0 to 163.0
|
69 mL
Interval 22.0 to 117.0
|
99 mL
Interval 52.0 to 145.0
|
112 mL
Interval 65.0 to 158.0
|
66 mL
Interval 17.0 to 115.0
|
55 mL
Interval 7.0 to 104.0
|
1 mL
Interval -48.0 to 49.0
|
164 mL
Interval 116.0 to 211.0
|
SECONDARY outcome
Timeframe: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)Population: MITT Population
Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 \[Treatment 1 Day 1\]
Outcome measures
| Measure |
GP MDI 18 µg BID
n=57 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Pre-dose Daily PEFR
|
8.6 L/min
Interval 2.1 to 15.1
|
6.2 L/min
Interval -0.3 to 12.8
|
2.0 L/min
Interval -4.5 to 8.5
|
4.4 L/min
Interval -2.1 to 10.9
|
0.3 L/min
Interval -6.4 to 6.9
|
-0.5 L/min
Interval -7.1 to 6.2
|
-6.3 L/min
Interval -12.7 to 0.2
|
14.8 L/min
Interval 8.2 to 21.4
|
SECONDARY outcome
Timeframe: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)Population: MITT Population
Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 \[Treatment 1 Day 1\]
Outcome measures
| Measure |
GP MDI 18 µg BID
n=57 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Post-dose Daily PEFR
|
33.5 L/min
Interval 25.8 to 40.4
|
26.7 L/min
Interval 19.4 to 33.9
|
20.2 L/min
Interval 13.0 to 27.4
|
20.3 L/min
Interval 13.1 to 27.5
|
14.8 L/min
Interval 7.5 to 22.2
|
14.3 L/min
Interval 6.9 to 21.7
|
5.3 L/min
Interval -1.9 to 12.5
|
39.8 L/min
Interval 32.5 to 47.1
|
SECONDARY outcome
Timeframe: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)Population: MITT Population
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=57 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Pre-dose Daily PEFR
|
15.7 L/min
Interval 8.8 to 22.5
|
14.9 L/min
Interval 8.1 to 21.7
|
7.2 L/min
Interval 0.5 to 13.9
|
11.7 L/min
Interval 4.9 to 18.5
|
5.0 L/min
Interval -1.9 to 12.0
|
6.9 L/min
Interval 0.0 to 13.8
|
5.7 L/min
Interval -1.1 to 12.6
|
—
|
SECONDARY outcome
Timeframe: Through the end of the 14-Day TreatmentPopulation: MITT Population
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Outcome measures
| Measure |
GP MDI 18 µg BID
n=57 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=58 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=59 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=58 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=56 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Post-dose Daily PEFR
|
41.4 L/min
Interval 33.6 to 49.2
|
32.7 L/min
Interval 24.9 to 40.5
|
24.7 L/min
Interval 16.9 to 32.4
|
27.0 L/min
Interval 19.3 to 34.8
|
19.4 L/min
Interval 11.5 to 27.3
|
22.7 L/min
Interval 14.8 to 30.6
|
13.5 L/min
Interval 5.8 to 21.3
|
35.9 L/min
Interval 28.1 to 43.8
|
SECONDARY outcome
Timeframe: Day 14 (End of treatment)Population: MITT Population
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Outcome measures
| Measure |
GP MDI 18 µg BID
n=59 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=61 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=60 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=68 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=58 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Number of Puffs of Rescue Medication (End of Treatment)
|
0.85 Puffs
Interval 0.56 to 1.28
|
1.25 Puffs
Interval 0.83 to 1.81
|
1.19 Puffs
Interval 0.83 to 1.66
|
1.11 Puffs
Interval 0.79 to 1.51
|
1.43 Puffs
Interval 1.02 to 1.95
|
1.57 Puffs
Interval 1.12 to 2.15
|
1.92 Puffs
Interval 1.39 to 2.56
|
0.87 Puffs
Interval 0.6 to 1.29
|
SECONDARY outcome
Timeframe: Day 1 through Day 14Population: MITT Population
Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Outcome measures
| Measure |
GP MDI 18 µg BID
n=58 Participants
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=59 Participants
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=60 Participants
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=59 Participants
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=55 Participants
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=55 Participants
GP MDI 0.6 µg BID.
|
Placebo MDI
n=56 Participants
Placebo MDI.
|
Spiriva® Handihaler®
n=57 Participants
Spiriva® Handihaler® (Tiotropium Bromide).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
|
0.088 Liter
Interval 0.053 to 0.123
|
0.087 Liter
Interval 0.052 to 0.121
|
0.090 Liter
Interval 0.056 to 0.124
|
0.086 Liter
Interval 0.052 to 0.12
|
0.056 Liter
Interval 0.021 to 0.091
|
0.023 Liter
Interval -0.013 to 0.058
|
0.001 Liter
Interval -0.034 to 0.036
|
0.141 Liter
Interval 0.107 to 0.176
|
Adverse Events
GP MDI 18 µg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GP MDI 9 µg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
GP MDI 4.6 µg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GP MDI 2.4 µg BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GP MDI 1.2 µg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GP MDI 0.6 µg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo MDI
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Spiriva 18 µg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GP MDI 18 µg BID
n=64 participants at risk
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=64 participants at risk
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=62 participants at risk
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=64 participants at risk
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=57 participants at risk
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=59 participants at risk
GP MDI 0.6 µg BID.
|
Placebo MDI
n=62 participants at risk
Placebo MDI.
|
Spiriva 18 µg
n=62 participants at risk
Spiriva 18 µg
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
1.6%
1/64 • Number of events 1 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/57 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/59 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
1.6%
1/62 • Number of events 1 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/57 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/59 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
1.6%
1/62 • Number of events 1 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
1.6%
1/64 • Number of events 1 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/57 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/59 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/64 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/57 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
1.7%
1/59 • Number of events 1 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
0.00%
0/62 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
Other adverse events
| Measure |
GP MDI 18 µg BID
n=64 participants at risk
GP MDI 18 µg BID.
|
GP MDI 9 µg BID
n=64 participants at risk
GP MDI 9 µg BID.
|
GP MDI 4.6 µg BID
n=62 participants at risk
GP MDI 4.6 µg BID.
|
GP MDI 2.4 µg BID
n=64 participants at risk
GP MDI 2.4 µg BID.
|
GP MDI 1.2 µg BID
n=57 participants at risk
GP MDI 1.2 µg BID.
|
GP MDI 0.6 µg BID
n=59 participants at risk
GP MDI 0.6 µg BID.
|
Placebo MDI
n=62 participants at risk
Placebo MDI.
|
Spiriva 18 µg
n=62 participants at risk
Spiriva 18 µg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
2/64 • Number of events 4 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
4.7%
3/64 • Number of events 3 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
4.8%
3/62 • Number of events 3 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
9.4%
6/64 • Number of events 7 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
5.3%
3/57 • Number of events 3 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
6.8%
4/59 • Number of events 5 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
4.8%
3/62 • Number of events 3 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
9.7%
6/62 • Number of events 7 • All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER