Staccato Loxapine Pulmonary Safety in Patients With COPD

NCT00889837 | Completed Phase 1 FDA Drug

• 2 other identifiers: AMDC-004-10813 April 2009
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Staccato Loxapine; COPD; pulmonary safety

Outcome Measures

Primary Outcomes (1)

• Change in FEV1 from baseline by spirometry

  at each post-treatment time point (15 min to 34 hr)

Secondary Outcomes (2)

• 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

Study Arms (2)

Inhaled Loxapine

EXPERIMENTAL

Staccato Loxapine, 10 mg doses x 2, 10 hours apart

Drug: Inhaled Loxapine

Inhaled Placebo

PLACEBO COMPARATOR

Staccato Placebo,inhalations x 2, 10 hours apart

Drug: Inhaled Placebo

Interventions

Inhaled Loxapine DRUG

Staccato Loxapine, 10 mg x 2 doses, 10 hours apart

Inhaled Loxapine

Inhaled Placebo DRUG

Staccato Placebo, inhalations x 2 , 10 hours apart

Inhaled Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and \>15 pack-year history of cigarette smoking.

You may not qualify if:

• History of asthma, or any other acute or chronic pulmonary disease.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (1)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Related 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.

  PMID: 24745666 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mildred D. Gottwald, PharmD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 14, 2017

Record last verified: 2009-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)