AsthmaPhase 1NCT02633007
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
A Phase 1 study testing CVT-301 (levodopa inhalation powder) and Carbidopa in people with Asthma, run by Acorda Therapeutics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- CVT-301 (levodopa inhalation powder) and Carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Site 003
Dallas, Texas, 75247
Site 002
Daytona Beach, Florida, 32117
Site 001
North Dartmouth, Massachusetts, 02747
About this study
Official title: A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
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.
- Conditions
- Asthma
- Being tested
- CVT-301 (levodopa inhalation powder), Carbidopa, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT-301 (levodopa inhalation powder)Drug
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.
CarbidopaDrug
Also called Lodosyn ®
Administered orally according to the carbidopa dosing schedule.
PlaceboOther
Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
| Study group | Role | What they receive |
|---|---|---|
| CVT-301 then Placebo (AB) | Experimental | 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. Receives: Drug: CVT-301 (levodopa inhalation powder); Drug: Carbidopa; Other: Placebo |
| Placebo then CVT-301 (BA) | Experimental | 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. Receives: Drug: CVT-301 (levodopa inhalation powder); Drug: Carbidopa; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary function
Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Measured: within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation
Secondary outcomes (4)
Number of subjects with Adverse Events (AEs) including Serious AEs
Measured: up to 12 days
Maximum observed plasma drug concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harald Murck, MD, PhD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633007
- Sponsor's protocol ID
- CVT-301-008
- Status last verified
- Jun 2016
- First submitted
- 11 Dec 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
- ClinicalTrials.gov ID
- NCT02633007
- Acronym / sponsor ID
- CVT-301-008
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVT-301 then Placebo (AB) | Experimental | Drug: CVT-301 (levodopa inhalation powder), Drug: Carbidopa, Other: PlaceboAll 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. |
| Placebo then CVT-301 (BA) | Experimental | Drug: CVT-301 (levodopa inhalation powder), Drug: Carbidopa, Other: PlaceboAll 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVT-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. | Drug | CVT-301 then Placebo (AB), Placebo then CVT-301 (BA) |
| CarbidopaAlso: Lodosyn ®Administered orally according to the carbidopa dosing schedule. | Drug | CVT-301 then Placebo (AB), Placebo then CVT-301 (BA) |
| PlaceboPlacebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa. | Other | CVT-301 then Placebo (AB), Placebo then CVT-301 (BA) |
Primary outcome
Change in pulmonary function
Time frame: 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)
4 secondary outcomes
Number of subjects with Adverse Events (AEs) including Serious AEs
Time frame: up to 12 days
Maximum observed plasma drug concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Murck, MD, PhD study director
Acorda Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVT-301 (levodopa inhalation powder) and Carbidopa in people with Asthma, run by Acorda Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary function (time frame: within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.