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Staccato Alprazolam in Panic Attack

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00477451
First received: May 22, 2007
Last updated: June 15, 2017
Last verified: June 2008
Results First Received: March 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Treatment of Induced Panic Attack
Interventions: Drug: Inhaled placebo
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 2 mg
Drug: IV doxapram

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    RCT Placebo   RCT Alprazolam 1 mg   Open Label Inhaled Alprazolam 1 mg   Initial Inhaled Alprazolam 2 mg
STARTED   20   20   7   2 
COMPLETED   20   20   7   2 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   RCT Placebo   RCT Alprazolam 1 mg   Open Label Inhaled Alprazolam 1 mg   Initial Inhaled Alprazolam 2 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   7   2   49 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      20 100.0%      7 100.0%      2 100.0%      49 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.2  (10.2)   32.1  (9.45)   43.1  (13.6)   37.5  (0.707)   34.3  (10.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      9  45.0%      12  60.0%      1  14.3%      1  50.0%      23  46.9% 
Male      11  55.0%      8  40.0%      6  85.7%      1  50.0%      26  53.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   20   20   7   2   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Doxapram-induced Panic Attack   [ Time Frame: 0 to 2 hours ]

2.  Primary:   Duration of the Doxapram-induced Panic Attack   [ Time Frame: 1 hr post-dose ]

3.  Secondary:   Borg Max Change From Baseline   [ Time Frame: 45 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Executive VP, Research & Development, Regulatory & Quality
Organization: Alexza Pharmaceuticals, Inc
phone: 650.944.7071
e-mail: ClinicalTrialsInfo@alexza.com



Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00477451     History of Changes
Other Study ID Numbers: AMDC-002-201
Study First Received: May 22, 2007
Results First Received: March 12, 2017
Last Updated: June 15, 2017