Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma (NCT NCT02105012)
NCT ID: NCT02105012
Last Updated: 2017-06-06
Results Overview
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Results posted on
2017-06-06
Participant Flow
Conducted at 44 sites in the US from May 2015 to September 2015. Study participation maximum of 32 weeks.
A Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma
Participant milestones
| Measure |
All Subjects
|
|---|---|
|
Overall Study
STARTED
|
147
|
|
Overall Study
BD MDI 320 µg
|
124
|
|
Overall Study
BD MDI 160 µg
|
132
|
|
Overall Study
BD MDI 80 µg
|
64
|
|
Overall Study
BD MDI 40 µg
|
63
|
|
Overall Study
Placebo MDI
|
127
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
All Subjects
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Protocol Specified Criteria
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Baseline characteristics by cohort
| Measure |
All Subjects
n=147 Participants
|
|---|---|
|
Age, Continuous
|
45.7 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)Population: Modified Intent to Treat Population (MITT)
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
Outcome measures
| Measure |
BD MDI 320 µg
n=109 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=109 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=56 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=56 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=111 Participants
Placebo MDI.
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
|
-0.002 Liters
Interval -0.036 to 0.033
|
-0.001 Liters
Interval -0.035 to 0.033
|
-0.034 Liters
Interval -0.081 to 0.014
|
-0.031 Liters
Interval -0.079 to 0.016
|
-0.116 Liters
Interval -0.15 to -0.082
|
SECONDARY outcome
Timeframe: Baseline to Last 7 Days of Treatment PeriodPopulation: MITT
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Outcome measures
| Measure |
BD MDI 320 µg
n=105 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=107 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=55 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=50 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=107 Participants
Placebo MDI.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
|
-5.802 Liters/min
Interval -17.937 to 6.333
|
-7.461 Liters/min
Interval -19.536 to 4.614
|
-9.992 Liters/min
Interval -24.293 to 4.309
|
-5.653 Liters/min
Interval -20.32 to 9.014
|
-29.933 Liters/min
Interval -42.019 to -17.847
|
SECONDARY outcome
Timeframe: Baseline to Last 7 Days of Treatment PeriodPopulation: MITT
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Outcome measures
| Measure |
BD MDI 320 µg
n=105 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=108 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=52 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=52 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=110 Participants
Placebo MDI.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
|
-7.345 Liters/min
Interval -18.394 to 3.703
|
-11.791 Liters/min
Interval -22.737 to -0.844
|
-14.403 Liters/min
Interval -28.118 to -0.688
|
-1.896 Liters/min
Interval -15.585 to 11.793
|
-32.807 Liters/min
Interval -43.712 to -21.902
|
SECONDARY outcome
Timeframe: Baseline to Last 7 Days of TreatmentPopulation: MITT
Change from baseline in mean number of puffs of rescue Ventolin HFA
Outcome measures
| Measure |
BD MDI 320 µg
n=111 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=115 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=56 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=56 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=114 Participants
Placebo MDI.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
|
-0.140 Puffs/Day
Interval -0.531 to 0.251
|
-0.268 Puffs/Day
Interval -0.654 to 0.119
|
-0.312 Puffs/Day
Interval -0.81 to 0.186
|
-0.095 Puffs/Day
Interval -0.592 to 0.402
|
0.606 Puffs/Day
Interval 0.218 to 0.994
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)Population: MITT
The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum
Outcome measures
| Measure |
BD MDI 320 µg
n=109 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=114 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=57 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=57 Participants
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=115 Participants
Placebo MDI.
|
|---|---|---|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
|
-0.575 Scores on a scale
Interval -0.73 to -0.42
|
-0.565 Scores on a scale
Interval -0.717 to -0.412
|
-0.515 Scores on a scale
Interval -0.714 to -0.317
|
-0.407 Scores on a scale
Interval -0.605 to -0.209
|
-0.100 Scores on a scale
Interval -0.252 to 0.052
|
Adverse Events
BD MDI 320 µg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BD MDI 160 µg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BD MDI 80 µg
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
BD MDI 40 µg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo MDI
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BD MDI 320 µg
n=124 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=132 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=64 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=63 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=127 participants at risk
Placebo MDI.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/124 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/132 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
1.6%
1/64 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/63 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/127 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/124 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/132 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
1.6%
1/64 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/63 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/127 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
Other adverse events
| Measure |
BD MDI 320 µg
n=124 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
|
BD MDI 160 µg
n=132 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
|
BD MDI 80 µg
n=64 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
|
BD MDI 40 µg
n=63 participants at risk
Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
|
Placebo MDI
n=127 participants at risk
Placebo MDI.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.2%
4/124 • Number of events 5 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.76%
1/132 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/64 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
1.6%
1/63 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.79%
1/127 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.4%
3/124 • Number of events 3 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
3.8%
5/132 • Number of events 5 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
1.6%
1/64 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
1.6%
1/63 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
3.1%
4/127 • Number of events 4 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/124 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.76%
1/132 • Number of events 1 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/64 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
0.00%
0/63 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
5.5%
7/127 • Number of events 7 • AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
|
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