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Staccato Loxapine Pulmonary Safety in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00789360
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:

November 7, 2008
November 11, 2008
May 5, 2009
November 2008
April 2009   (Final data collection date for primary outcome measure)
Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 32 hr) ]
Same as current
Complete list of historical versions of study NCT00789360 on ClinicalTrials.gov Archive Site
  • Change in FVC from baseline by spirometry [ Time Frame: Post-treatment time points ]
  • Treatment emergent adverse events [ Time Frame: Post-treatment time points ]
Same as current
Not Provided
Not Provided
 
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: Placebo -- Active
    Placebo followed by Active (Staccato Loxapine, 10 mg x 2)
  • Drug: Active -- Placebo
    Active (Staccato Loxapine, 10 mg x 2) followed by Placebo
  • Experimental: 1
    Placebo -- Active
    Intervention: Drug: Placebo -- Active
  • Experimental: 2
    Active -- Placebo
    Intervention: Drug: Active -- Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Exclusion Criteria:

  • history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00789360
AMDC-004-104
12 September 2008
No
Not Provided
Not Provided
Robert Fishman, MD., Vice President, Clinical Development, Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
Principal Investigator: David S. Miller, MD Northeast Medical Research, North Dartmouth, MA
Alexza Pharmaceuticals, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP