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Staccato Loxapine Pulmonary Safety in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00890175
First received: April 27, 2009
Last updated: March 13, 2017
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: Inhaled loxapine @ 0 & 10 h
Drug: Inhaled placebo @ 2 & 10 hours
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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) ]

Secondary Outcome 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 ]

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: Inhaled loxapine @ 0 & 10 h
Inhalation of 10 mg of loxapine at 0 and 10 hours
Drug: Inhaled loxapine @ 0 & 10 h
10 mg, 2 doses, 10 hours apart
Other Name: ADASUVE
Placebo Comparator: Inhaled placebo @ 2 & 10 hours
Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours
Drug: Inhaled placebo @ 2 & 10 hours
placebo, 2 doses, 10 hours apart
Other Name: ADASUVE PLACEBO

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Alexza Pharmaceuticals, 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: March 13, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 28, 2017