Staccato Loxapine Pulmonary Safety in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00890175
First received: April 27, 2009
Last updated: August 28, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Staccato Loxapine
Drug: Staccato Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in FEV1 from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in FVC from baseline by spirometry [ Time Frame: at each post-treatment time point (15 min to 34 hr) ] [ Designated as safety issue: Yes ]
  • Treatment emergent adverse events [ Time Frame: Post-treatment time points ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Staccato Loxapine
2 doses 10 hours apart
Placebo Comparator: 2 Drug: Staccato Placebo
2 doses 10 hours apart

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890175

Locations
United States, California
Allergy and Asthma Medical Group & Research Center, A.P.C.
San Diego, California, United States, 92123
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Study Director: Mildred D. Gottwald, PharmD Alexza Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuitcals, Inc.
ClinicalTrials.gov Identifier: NCT00890175     History of Changes
Other Study ID Numbers: AMDC-004-105, 10 April 2009
Study First Received: April 27, 2009
Last Updated: August 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Asthma, Staccato loxapine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loxapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014