Staccato Loxapine Pulmonary Safety in Patients With COPD
Phase 1
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Inhaled Placebo
- Registration Number
- NCT00889837
- Lead Sponsor
- Alexza Pharmaceuticals, Inc.
- 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.
- Detailed Description
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
- History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.
Exclusion Criteria
- History of asthma, or any other acute or chronic pulmonary disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Placebo Inhaled Placebo Staccato Placebo,inhalations x 2, 10 hours apart Inhaled Loxapine Inhaled Loxapine Staccato Loxapine, 10 mg doses x 2, 10 hours apart
- 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 Treatment emergent adverse events Post-treatment time points Change in FVC from baseline by spirometry at each post-treatment time point (15 min to 34 hr)
Trial Locations
- Locations (1)
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States