Staccato Loxapine Pulmonary Safety in Patients With Asthma

Overview

The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.

Full Title of Study: “Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2009

Interventions

  • Drug: Inhaled loxapine @ 0 & 10 h
    • 10 mg, 2 doses, 10 hours apart
  • Drug: Inhaled placebo @ 2 & 10 hours
    • placebo, 2 doses, 10 hours apart

Arms, Groups and Cohorts

  • Experimental: Inhaled loxapine @ 0 & 10 h
    • Inhalation of 10 mg of loxapine at 0 and 10 hours
  • Placebo Comparator: Inhaled placebo @ 2 & 10 hours
    • Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours

Clinical Trial Outcome Measures

Primary Measures

  • Change in FEV1 from baseline by spirometry
    • Time Frame: at each post-treatment time point (15 min to 34 hr)

Secondary Measures

  • Change in FVC from baseline by spirometry
    • Time Frame: at each post-treatment time point (15 min to 34 hr)
  • Treatment emergent adverse events
    • Time Frame: Post-treatment time points

Participating in This Clinical Trial

Inclusion Criteria

  • History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value. Exclusion Criteria:

  • History of COPD, or any other acute or chronic pulmonary disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alexza Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mildred D. Gottwald, PharmD, Study Director, Alexza Pharmaceuticals, Inc.

References

Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease–two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.

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