Trial Outcomes & Findings for Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3 (NCT NCT02322788)
NCT ID: NCT02322788
Last Updated: 2017-01-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
Results posted on
2017-01-13
Participant Flow
Patients with stable, mild to moderate asthma were enrolled. The first subject entered study on March 10, 2015 and the last subject completed study on November 5, 2015. Subjects were recuited from Site 1001 and 1002 in Canada, Site 7201 in Sweden, and Site 5001 in Netherlands.
Of the 95 patients enrolled 34 were screen failures mainly due to not fulfilling specific randomization criteria on stability in asthma or sensitivity to methacholine challenge; 1 was withdrawal by subject; 72 entered run in period. A total of 60 patients were randomized to the 4 single-dose treatments with terbutaline in a crossover design.
Participant milestones
| Measure |
M2 0.5 mg
0.5 mg terbutaline sulphate administered via Turbuhaler M2
|
M2 1.5 mg
1.5 mg terbutaline sulphate administered via Turbuhaler M2
|
M3 0.5 mg
0.5 mg terbutaline sulphate administered via Turbuhaler M3
|
M3 1.5 mg
1.5 mg terbutaline sulphate administered via Turbuhaler M3
|
|---|---|---|---|---|
|
Visit 3
STARTED
|
15
|
15
|
14
|
16
|
|
Visit 3
COMPLETED
|
15
|
15
|
14
|
16
|
|
Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Visit 4
STARTED
|
15
|
14
|
16
|
15
|
|
Visit 4
COMPLETED
|
15
|
14
|
16
|
15
|
|
Visit 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Visit 5
STARTED
|
16
|
15
|
15
|
14
|
|
Visit 5
COMPLETED
|
16
|
15
|
15
|
14
|
|
Visit 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Visit 6
STARTED
|
14
|
16
|
15
|
15
|
|
Visit 6
COMPLETED
|
14
|
16
|
15
|
15
|
|
Visit 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3
Baseline characteristics by cohort
| Measure |
Overall
n=60 Participants
Total number of participants in the Full analysis set
|
|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
|
Gender
Female
|
40 Participants
n=5 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periodsPopulation: Efficacy analysis set
Outcome measures
| Measure |
M3 1.5 mg
n=60 Participants
1.5 mg terbutaline sulphate administered via Turbuhaler M3
|
M3 0.5 mg
n=60 Participants
0.5 mg terbutaline sulphate administered via Turbuhaler M3
|
M2 1.5 mg
n=60 Participants
1.5 mg terbutaline sulphate administered via Turbuhaler M2
|
M2 0.5 mg
n=60 Participants
0.5 mg terbutaline sulphate administered via Turbuhaler M2
|
|---|---|---|---|---|
|
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
|
17.70 mg/mL
Interval 12.51 to 25.05
|
9.88 mg/mL
Interval 6.98 to 13.99
|
20.10 mg/mL
Interval 14.2 to 28.45
|
10.78 mg/mL
Interval 7.61 to 15.25
|
Adverse Events
M2 0.5 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
M2 1.5 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
M3 0.5 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
M3 1.5 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M2 0.5 mg
n=60 participants at risk
0.5 mg terbutaline sulphate administered via Turbuhaler M2
|
M2 1.5 mg
n=60 participants at risk
1.5 mg terbutaline sulphate administered via Turbuhaler M2
|
M3 0.5 mg
n=60 participants at risk
0.5 mg terbutaline sulphate administered via Turbuhaler M3
|
M3 1.5 mg
n=60 participants at risk
1.5 mg terbutaline sulphate administered via Turbuhaler M3
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 2 • During randomized treatment period from Visit 3 to Visit 6
|
3.3%
2/60 • Number of events 2 • During randomized treatment period from Visit 3 to Visit 6
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
|
General disorders
Chest discomfort
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/60 • Number of events 2 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Nervous system disorders
Dysgeusia
|
10.0%
6/60 • Number of events 6 • During randomized treatment period from Visit 3 to Visit 6
|
10.0%
6/60 • Number of events 6 • During randomized treatment period from Visit 3 to Visit 6
|
8.3%
5/60 • Number of events 5 • During randomized treatment period from Visit 3 to Visit 6
|
11.7%
7/60 • Number of events 7 • During randomized treatment period from Visit 3 to Visit 6
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
|
Nervous system disorders
Sciatica
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
|
Nervous system disorders
Tremor
|
3.3%
2/60 • Number of events 2 • During randomized treatment period from Visit 3 to Visit 6
|
5.0%
3/60 • Number of events 3 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
8.3%
5/60 • Number of events 5 • During randomized treatment period from Visit 3 to Visit 6
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
0.00%
0/60 • During randomized treatment period from Visit 3 to Visit 6
|
1.7%
1/60 • Number of events 1 • During randomized treatment period from Visit 3 to Visit 6
|
Additional Information
Göran Eckerwall, MD, PhD
AstraZeneca R&D Gothenburg, SE-431 83 Mölndal, Sweden
Phone: +46 708467664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60