Trial Outcomes & Findings for Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma (NCT NCT01641081)
NCT ID: NCT01641081
Last Updated: 2017-02-28
Results Overview
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
174 participants
Primary outcome timeframe
Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
Results posted on
2017-02-28
Participant Flow
The study was conducted in 29 study centers in the United States First patient visit was in June 2012 and last patient visit was in February 2013
A total of 408 patients were screened; there were 234 screen failures, primarily (225/234) because inclusion/exclusion criteria were not met
Participant milestones
| Measure |
Sequence 1
24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
|
Sequence 2
12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
|
Sequence 3
Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
|
Sequence 4
Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
|
Sequence 5
Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
|
Sequence 6
Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
|
Sequence 7
Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
|
Sequence 8
24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
|
Sequence 9
12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
|
Sequence 10
Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
18
|
18
|
15
|
22
|
17
|
19
|
19
|
17
|
15
|
14
|
|
Period 1
COMPLETED
|
17
|
18
|
15
|
22
|
16
|
19
|
18
|
14
|
15
|
14
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
3
|
0
|
0
|
|
Period 2
STARTED
|
17
|
18
|
15
|
22
|
16
|
19
|
18
|
14
|
15
|
14
|
|
Period 2
COMPLETED
|
16
|
18
|
15
|
21
|
16
|
18
|
16
|
14
|
15
|
14
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Period 3
STARTED
|
16
|
18
|
15
|
21
|
16
|
18
|
16
|
14
|
15
|
14
|
|
Period 3
COMPLETED
|
16
|
18
|
14
|
21
|
16
|
18
|
16
|
14
|
14
|
14
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 4
STARTED
|
16
|
18
|
14
|
21
|
16
|
18
|
16
|
14
|
14
|
14
|
|
Period 4
COMPLETED
|
16
|
17
|
14
|
20
|
16
|
18
|
16
|
14
|
14
|
14
|
|
Period 4
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
16
|
17
|
14
|
20
|
16
|
18
|
16
|
14
|
14
|
14
|
|
Period 5
COMPLETED
|
16
|
17
|
12
|
20
|
16
|
18
|
16
|
14
|
14
|
14
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
|
Sequence 2
12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
|
Sequence 3
Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
|
Sequence 4
Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
|
Sequence 5
Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
|
Sequence 6
Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
|
Sequence 7
Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
|
Sequence 8
24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
|
Sequence 9
12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
|
Sequence 10
Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Sponsor request (potential unblinding)
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 1
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Period 2
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 4
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=174 Participants
All patients participating in the crossover study
|
|---|---|
|
Age, Continuous
|
45.4 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
91 Participants
n=5 Participants
|
|
Gender
Male
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatmentPopulation: Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Outcome measures
| Measure |
Foradil 24 μg
n=155 Participants
Administered via Aerolizer
|
Foradil 12 μg
n=151 Participants
Administered via Aerolizer
|
Formoterol 12 μg
n=155 Participants
Administered via Pressair
|
Formoterol 6 μg
n=159 Participants
Administered via Pressair
|
Placebo
n=154 Participants
Administered via Pressair
|
|---|---|---|---|---|---|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
|
0.3196 Liters
Standard Error 0.0382
|
0.3076 Liters
Standard Error 0.0382
|
0.2795 Liters
Standard Error 0.0382
|
0.2726 Liters
Standard Error 0.0381
|
0.0552 Liters
Standard Error 0.0382
|
SECONDARY outcome
Timeframe: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatmentPopulation: Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Outcome measures
| Measure |
Foradil 24 μg
n=163 Participants
Administered via Aerolizer
|
Foradil 12 μg
n=155 Participants
Administered via Aerolizer
|
Formoterol 12 μg
n=159 Participants
Administered via Pressair
|
Formoterol 6 μg
n=158 Participants
Administered via Pressair
|
Placebo
n=154 Participants
Administered via Pressair
|
|---|---|---|---|---|---|
|
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
|
0.3544 Liters
Standard Error 0.0196
|
0.3068 Liters
Standard Error 0.0198
|
0.2712 Liters
Standard Error 0.0197
|
0.2204 Liters
Standard Error 0.0197
|
0.0306 Liters
Standard Error 0.0198
|
Adverse Events
Foradil 24 μg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Foradil 12 μg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Formoterol 12 μg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Formoterol 6 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Foradil 24 μg
n=167 participants at risk
Administered via Aerolizer
|
Foradil 12 μg
n=163 participants at risk
Administered via Aerolizer
|
Formoterol 12 μg
n=164 participants at risk
Administered via Pressair
|
Formoterol 6 μg
n=166 participants at risk
Administered via Pressair
|
Placebo
n=165 participants at risk
Administered via Pressair
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/167 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.61%
1/163 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/164 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/166 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/165 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/167 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.61%
1/163 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/164 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/166 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/165 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
Other adverse events
| Measure |
Foradil 24 μg
n=167 participants at risk
Administered via Aerolizer
|
Foradil 12 μg
n=163 participants at risk
Administered via Aerolizer
|
Formoterol 12 μg
n=164 participants at risk
Administered via Pressair
|
Formoterol 6 μg
n=166 participants at risk
Administered via Pressair
|
Placebo
n=165 participants at risk
Administered via Pressair
|
|---|---|---|---|---|---|
|
Nervous system disorders
Tremor
|
6.0%
10/167 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
1.2%
2/163 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
1.2%
2/164 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.60%
1/166 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
0.00%
0/165 • Day 14±1 of the final treatment period (Period 5)
The Safety Population consisted of all patients screened, randomized to a treatment sequence, and who took at least one dose of double-blind investigational product The total number of patients in the Safety Population was 174; due to study drop-out and the crossover study design, not all patients received all treatments
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results by the PI will be subject to mutual agreement between the PI and sponsor.
- Publication restrictions are in place
Restriction type: OTHER