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OpenTrials
Completed

NCT Number: NCT00789360

Staccato Loxapine Pulmonary Safety in Healthy Volunteers

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northeast Medical Research

North Dartmouth, Massachusetts, 02747, United States

About this study

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled placebo

Drug

Inhaled Staccato Placebo, 2 inhalations, 8 hours apart

Inhaled loxapine

Drug

Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Primary outcomes

  1. The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry

    Time frame: 17 post-treatment time points (15 min to 32 hr)

    The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,

Secondary outcomes

  1. The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry

    Time frame: 17 post-treatment time points (15 min to 32 hr)

    The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2008
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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