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Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Placebo -- Active (Drug); Active -- Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
David S. Miller, MD, Principal Investigator, Affiliation: Northeast Medical Research, North Dartmouth, MA

Summary

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

Clinical Details

Official title: Pulmonary Safety of Repeat Doses of StaccatoŽ Loxapine for Inhalation in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in FEV1 from baseline by spirometry

Secondary outcome:

Change in FVC from baseline by spirometry

Treatment emergent adverse events

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Northeast Medical Research, North Dartmouth, Massachusetts 02747, United States
Additional Information

Starting date: November 2008
Last updated: May 4, 2009

Page last updated: August 23, 2015

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