Staccato Loxapine Pulmonary Safety in Patients With Asthma

Asthma Clinical Trial

Official title:

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890175
• Other study ID #: AMDC-004-105
• Secondary ID: 10 April 2009
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2009
• Last updated: March 13, 2017
• Start date: May 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Allergy and Asthma Medical Group & Research Center, A.P.C.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 from baseline by spirometry		at each post-treatment time point (15 min to 34 hr)
Secondary	Change in FVC from baseline by spirometry		at each post-treatment time point (15 min to 34 hr)
Secondary	Treatment emergent adverse events		Post-treatment time points