Chronic Obstructive Pulmonary DiseasePhase 1NCT01551316
Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study testing MN-221 in people with Chronic Obstructive Pulmonary Disease, run by MediciNova at 2 sites in United States.
Trial summary
In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MN-221
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to May 2012
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 40-75 years of age, inclusive;
- History of physician-diagnosed (e.g., by clinical history, >15-pack year history of smoking, physical examination, and spirometry) COPD treated for ≥ 3 months prior to Visit 1 Pre-Screening;
- FEV1 ≥ 30% and < 80% predicted and FEV1/FVC ratio < 0.7 at Visit 1 Pre-Screening and Visit 2 Screening;
- Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation);
- Negative urine drug screen for cocaine, phencyclidine (PCP), methamphetamine;
- Negative alcohol breath test;
Show all 10Show fewer
- Electrocardiogram (ECG) without serious abnormality and with QTcB and QTcF < 460 milliseconds (msec);
- Ability to wash-out of concomitant LABA and Theophylline, if ongoing, for 7-8 days (i.e., Visit 2 Screening through 5-Day Treatment Period).
- Legally effective written informed consent obtained prior to starting any study procedures.
- Subject willing and able to comply with the protocol and procedures, as judged by Investigator.
Who cannot join
- Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 48 hours prior to treatment start (Day 1);
- Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 60 days of Visit 2 Screening;
- Antibiotic therapy for respiratory infection ≤ 15 days of Visit 2 Screening;
- Presence of active respiratory disease such as pneumonia and acute exacerbation of chronic bronchitis;
- Hypokalemia defined as a potassium level <3.0 mmol/L at Visit 2 Screening. note: Subjects <3.0 mmol/L may be re-screened at Visit 2 Screening after receiving potassium replacement therapy;
- Significant clinical laboratory abnormality that, in the opinion of the Investigator, may put the subject at risk;
Show all 15Show fewer
- Significant renal, hepatic, endocrine, neurologic or other systemic disease that, in the opinion of the Investigator, may put the subject at undue risk;
- Uncontrolled hypertension (defined as a blood pressure ≥ 170/100 mm Hg at Visit 1 Pre-Screening) and/or uncontrolled angina, uncontrolled diabetes, uncontrolled congestive heart failure (CHF), uncontrolled serious arrhythmia;
- Myocardial infarction within 6 months of treatment start;
- Pregnant or lactating females;
- Participation in another clinical study with an investigational drug within 30 days of Visit 1 Pre-Screening;
- Patients with home oxygen requirements.
- A known allergy to excipients of the MN-221 drug product;
- A known allergy to other beta agonists;
- Currently on medication/s that are recognized to have risk of Torsades de Pointes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Texas Health Research
New Braunfels, Texas, 78130
Sylvana Research Associates
San Antonio, Texas, 78229
About this study
Official title: A Phase Ib Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Repeated Administration, Intravenous MN-221 in Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus, the primary objective of this clinical study is to determine the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to placebo with repeated administration over several days in moderate to severe COPD patients who may also have co-morbidities and concomitant medications (CM) common in this population. Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).
This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human clinical trial information.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MN-221, Placebo
- Keywords
- safety, pharmacokinetics, spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN-221Drug
Also called Bedoradrine Sulfate
This drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once).
PlaceboDrug
This intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4.
| Study group | Role | What they receive |
|---|---|---|
| MN-221 | Experimental | If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. Receives: Drug: MN-221 |
| PLACEBO | Experimental | If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.
Measured: Treatment Days 1- 5
Secondary outcomes (2)
MN-221 and primary metabolite levels will be analyzed by liquid chromatography/mass spectrometry/mass spectrometry.
Blood samples will be analyzed for MN-221 and primary metabolite levels by liquid chromatography/mass spectrometry (LC/MS/MS.
Measured: Treatment Days 1-5
Evaluation of respiratory parameters (FEV1, peak flow, accessory muscle use, respiratory rate)
Measured: Screening, Treatment Days 1,3,5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551316
- Sponsor's protocol ID
- MN-221-CL-012
- Status last verified
- May 2012
- First submitted
- 8 Feb 2012
- Last updated
- 21 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Repeated Administration, Intravenous MN-221 in Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT01551316
- Acronym / sponsor ID
- MN-221-CL-012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- safety, pharmacokinetics, spirometry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Mar 2012 (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.
In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus, the primary objective of this clinical study is to determine the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to placebo with repeated administration over several days in moderate to severe COPD patients who may also have co-morbidities and concomitant medications (CM) common in this population. Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).
This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human clinical trial information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MN-221 | Experimental | Drug: MN-221If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. |
| PLACEBO | Experimental | Drug: PlaceboIf the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 40-75 years of age, inclusive;
- History of physician-diagnosed (e.g., by clinical history, >15-pack year history of smoking, physical examination, and spirometry) COPD treated for ≥ 3 months prior to Visit 1 Pre-Screening;
- FEV1 ≥ 30% and < 80% predicted and FEV1/FVC ratio < 0.7 at Visit 1 Pre-Screening and Visit 2 Screening;
- Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation);
- Negative urine drug screen for cocaine, phencyclidine (PCP), methamphetamine;
Key exclusion criteria (15 listed)
- Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 48 hours prior to treatment start (Day 1);
- Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 60 days of Visit 2 Screening;
- Antibiotic therapy for respiratory infection ≤ 15 days of Visit 2 Screening;
- Presence of active respiratory disease such as pneumonia and acute exacerbation of chronic bronchitis;
- Hypokalemia defined as a potassium level <3.0 mmol/L at Visit 2 Screening. note: Subjects <3.0 mmol/L may be re-screened at Visit 2 Screening after receiving potassium replacement therapy;
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 |
|---|---|---|
| MN-221Also: Bedoradrine SulfateThis drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once). | Drug | MN-221 |
| PlaceboThis intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4. | Drug | PLACEBO |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Treatment Days 1- 5
The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.
2 secondary outcomes
MN-221 and primary metabolite levels will be analyzed by liquid chromatography/mass spectrometry/mass spectrometry.
Time frame: Treatment Days 1-5
Evaluation of respiratory parameters (FEV1, peak flow, accessory muscle use, respiratory rate)
Time frame: Screening, Treatment Days 1,3,5
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 21 May 2012.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 MN-221 in people with Chronic Obstructive Pulmonary Disease, run by MediciNova at 2 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 10 inclusion and 15 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Treatment Days 1- 5). 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 21 May 2012.