Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Staccato Loxapine, COPD, pulmonary safety
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.
Interventions
DRUGInhaled Loxapine
Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
DRUGInhaled Placebo
Staccato Placebo, inhalations x 2 , 10 hours apart
Sponsors
Alexza Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 from baseline by spirometry | at each post-treatment time point (15 min to 34 hr) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed