Staccato Loxapine Pulmonary Safety in Patients With Asthma

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Inhaled loxapine @ 0 & 10 h; Drug: Inhaled placebo @ 2 & 10 hours

• Registration Number: NCT00890175
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-05
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled loxapine @ 0 & 10 h	Inhaled loxapine @ 0 & 10 h	Inhalation of 10 mg of loxapine at 0 and 10 hours
Inhaled placebo @ 2 & 10 hours	Inhaled placebo @ 2 & 10 hours	Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Allergy and Asthma Medical Group & Research Center, A.P.C.; 🇺🇸 San Diego, California, United States