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A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

Acorda Therapeutics logo

Acorda Therapeutics

Status and phase

Completed
Phase 1

Conditions

Asthma

Treatments

Drug: CVT-301 (levodopa inhalation powder)
Drug: Carbidopa
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02633007
CVT-301-008

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

25 participants in 2 patient groups

CVT-301 then Placebo (AB)
Experimental group
Description:
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA \[CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)\] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
Treatment:
Other: Placebo
Drug: CVT-301 (levodopa inhalation powder)
Drug: Carbidopa
Placebo then CVT-301 (BA)
Experimental group
Description:
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA \[CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)\] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
Treatment:
Other: Placebo
Drug: CVT-301 (levodopa inhalation powder)
Drug: Carbidopa

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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