Trial Outcomes & Findings for Staccato Alprazolam in Panic Attack (NCT NCT00477451)
NCT ID: NCT00477451
Last Updated: 2017-06-16
Results Overview
doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
0 to 2 hours
Results posted on
2017-06-16
Participant Flow
Participant milestones
| Measure |
RCT Placebo
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Open Label Inhaled Alprazolam 1 mg
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Initial Inhaled Alprazolam 2 mg
Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
7
|
2
|
|
Overall Study
COMPLETED
|
20
|
20
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Staccato Alprazolam in Panic Attack
Baseline characteristics by cohort
| Measure |
RCT Placebo
n=20 Participants
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
n=20 Participants
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Open Label Inhaled Alprazolam 1 mg
n=7 Participants
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Initial Inhaled Alprazolam 2 mg
n=2 Participants
Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
49 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 10.2 • n=39 Participants
|
32.1 years
STANDARD_DEVIATION 9.45 • n=41 Participants
|
43.1 years
STANDARD_DEVIATION 13.6 • n=35 Participants
|
37.5 years
STANDARD_DEVIATION 0.707 • n=31 Participants
|
34.3 years
STANDARD_DEVIATION 10.66 • n=146 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
26 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
49 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 0 to 2 hoursPopulation: RCT Population (N=40)
doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
Outcome measures
| Measure |
RCT Placebo
n=20 Participants
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
n=20 Participants
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
|---|---|---|
|
Number of Participants With Doxapram-induced Panic Attack
|
14 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 1 hr post-dosePopulation: RCT Population (N=40)
Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)
Outcome measures
| Measure |
RCT Placebo
n=20 Participants
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
n=20 Participants
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
|---|---|---|
|
Duration of the Doxapram-induced Panic Attack
|
12.2 minutes
Standard Deviation 17.2
|
9.25 minutes
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 45 minutesPopulation: RCT Population (N=40)
Subjects asked to "Point to the number (0 to 10) which matches how breathless you feel now" where 0=nothing at all to 10=very, very strong
Outcome measures
| Measure |
RCT Placebo
n=20 Participants
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
n=20 Participants
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
|---|---|---|
|
Borg Max Change From Baseline
|
5.73 units on a scale
Standard Deviation 2.85
|
4.63 units on a scale
Standard Deviation 2.56
|
Adverse Events
RCT Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RCT Alprazolam 1 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Open Label Inhaled Alprazolam 1 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Initial Inhaled Alprazolam 2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RCT Placebo
n=20 participants at risk
Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
RCT Alprazolam 1 mg
n=20 participants at risk
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Open Label Inhaled Alprazolam 1 mg
n=7 participants at risk
Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
Initial Inhaled Alprazolam 2 mg
n=2 participants at risk
Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
50.0%
1/2 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/20 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
50.0%
1/2 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/20 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
SEDATION
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
45.0%
9/20 • Number of events 9 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
50.0%
1/2 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/20 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
|
Additional Information
Executive VP, Research & Development, Regulatory & Quality
Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60