Trial Outcomes & Findings for Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg (NCT NCT01256086)
NCT ID: NCT01256086
Last Updated: 2022-02-11
Results Overview
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
60 min after application of study medication
Results posted on
2022-02-11
Participant Flow
First patient was enrolled in December 2010, last patient completed in July 2011
During screening phase (within 14 days before but at latest 2 days before randomisation), 2 methacholine tests on separate days (with and without pre-medication) were performed to check the suitability of the patients.
Participant milestones
| Measure |
N1A2A1N2
Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
|
A1N1N2A2
Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
|
N2A1A2N1
Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
|
A2N2N1A1
Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
|
|---|---|---|---|---|
|
Treatment Day 1
STARTED
|
11
|
11
|
11
|
11
|
|
Treatment Day 1
COMPLETED
|
11
|
11
|
11
|
11
|
|
Treatment Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Day 2
STARTED
|
11
|
10
|
9
|
11
|
|
Treatment Day 2
COMPLETED
|
11
|
10
|
9
|
11
|
|
Treatment Day 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Day 3
STARTED
|
11
|
10
|
9
|
11
|
|
Treatment Day 3
COMPLETED
|
11
|
10
|
9
|
11
|
|
Treatment Day 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Day 4
STARTED
|
11
|
10
|
9
|
11
|
|
Treatment Day 4
COMPLETED
|
11
|
10
|
9
|
11
|
|
Treatment Day 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg
Baseline characteristics by cohort
| Measure |
N1A2A1N2
n=11 Participants
Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
|
A1N1N2A2
n=11 Participants
Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
|
N2A1A2N1
n=11 Participants
Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
|
A2N2N1A1
n=11 Participants
Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 12 • n=5 Participants
|
35 years
STANDARD_DEVIATION 13 • n=7 Participants
|
26 years
STANDARD_DEVIATION 10 • n=5 Participants
|
28 years
STANDARD_DEVIATION 11 • n=4 Participants
|
30 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
44 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 60 min after application of study medicationPopulation: Per Protocol Population
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
Outcome measures
| Measure |
24 µg Formoterol Novolizer
n=38 Participants
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
12µg Formoterol Novolizer
n=38 Participants
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
24 µg Formoterol Aerolizer
n=38 Participants
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
|
12µg Formoterol Aerolizer
n=38 Participants
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
|
|---|---|---|---|---|
|
PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)
|
35.0 mg/ml
Geometric Coefficient of Variation 138.8
|
20.9 mg/ml
Geometric Coefficient of Variation 130.1
|
33.2 mg/ml
Geometric Coefficient of Variation 96.4
|
17.8 mg/ml
Geometric Coefficient of Variation 172.2
|
Adverse Events
24 µg Formoterol Novolizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12µg Formoterol Novolizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
24 µg Formoterol Aerolizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12µg Formoterol Aerolizer
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24 µg Formoterol Novolizer
n=43 participants at risk
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
12µg Formoterol Novolizer
n=41 participants at risk
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
24 µg Formoterol Aerolizer
n=41 participants at risk
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
|
12µg Formoterol Aerolizer
n=42 participants at risk
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
laryngeal cancer stage 0
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
24 µg Formoterol Novolizer
n=43 participants at risk
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
12µg Formoterol Novolizer
n=41 participants at risk
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
|
24 µg Formoterol Aerolizer
n=41 participants at risk
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
|
12µg Formoterol Aerolizer
n=42 participants at risk
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
|
|---|---|---|---|---|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
Additional Information
Prof. Dr. Leslie Hendeles
University of Florida, Department of Pharmacotherapy and Tanslational Research, 100486 Gainesville, FL 32610
Phone: +1 352 279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee INSTITUTION shall have the right to publish the results of its part of the study either independently or in collaboration with SPONSOR.In either case, INSTITUTION agrees to submit a copy of any manuscript and/or abstract to SPONSOR for review and comment sixty (60) days prior to its submission for publication. SPONSOR shall have said sixty (60) day period to respond to INSTITUTION with any requested revisions. INSTITUTION agrees to delete information identified by SPONSOR as confidential.
- Publication restrictions are in place
Restriction type: OTHER