A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Completed · Phase 1 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT02633007
- Run by
- Acorda Therapeutics
- People needed
- 25
- Starts
- 2015-12-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2016-06-13
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%.
You may not qualify if…
- 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.
Where it is running
- Site 002 — Daytona Beach, Florida, United States
- Site 001 — North Dartmouth, Massachusetts, United States
- Site 003 — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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