Asthma
Conditions
Brief summary
This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.
Interventions
DRUGCVT-301 (levodopa inhalation powder)
Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
DRUGCarbidopa
Administered orally according to the carbidopa dosing schedule.
OTHERPlacebo
Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
Sponsors
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma; * On a stable regimen of asthma medications for at least 30 days prior to screening; * Body mass index (BMI) 18 to 32 kg/m2; * Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height; * FEV1/FVC (forced vital capacity) ratio ≥70%.
Exclusion criteria
* More than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness; * Asthma exacerbation within 8 weeks before screening; * Unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening; * History of intubation or intensive care unit admission for asthma in the past 5 years; * History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years; * Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulmonary function | within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation | Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III) |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with Adverse Events (AEs) including Serious AEs | up to 12 days |
| Maximum observed plasma drug concentration (Cmax) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
| Time to maximum observed plasma drug concentration (Tmax) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
| Area under the concentration time curve over the dosing interval (AUC0-last) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
Countries
United States
Outcome results
None listed