Chronic Obstructive Pulmonary DiseasePhase 1NCT01013142
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing MN-221 (Dose Group 1), MN-221 (Dose Group 2) and MN-221 (Dose Group 3) in people with Chronic Obstructive Pulmonary Disease, run by MediciNova at 7 sites in United States.
Trial summary
The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MN-221 (Dose Group 1), MN-221 (Dose Group 2) and MN-221 (Dose Group 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2009to Mar 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 40-65 years of age, inclusive;
- History of physician-diagnosed COPD treated for ≥ 3 months ;
- FEV1 ≥ 30% < 80% and FEV1/FVC ratio < 0.7 at screening;
- An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol;
- 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, PCP, methamphetamine;
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- ECG with no evidence of ischemic heart disease or dysrhythmias and otherwise normal or with findings considered not clinically significant at screening;
- QTcB and QTcF < 450 msec;
- No clinical evidence of active ischemic heart disease as determined by the Investigator; and
- Legally effective written informed consent obtained prior to starting any study procedures.
Who cannot join
- Beta agonist and/or anticholinergic via inhaler or intravenously ≤ 6 hours of screening;
- Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 24 hours prior to screening;
- A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema;
- Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 90 days of screening;
- Antibiotic therapy for respiratory infection ≤ 30 days of screening;
- Presence of active respiratory disease such as pneumonia, or acute bronchitis;
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- History or presence of tachyarrhythmias, with the exception of sinus tachycardia;
- Hypokalemia defined as a potassium level ≤ 3.0 mmol/L at screening;
- Significant renal, hepatic, endocrine, metabolic, neurologic or other systemic disease;
- Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg at screening;
- Pregnant or lactating females;
- Participation in another clinical study with an investigational drug within 30 days of screening;
- A known allergy to excipients of the MN-221 drug product;
- A known allergy to other beta agonists;
- Previous exposure to MN-221; or
- Use of beta blockers, MAO inhibitors, or tricyclic antidepressants ≤ 2 weeks prior to screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
SNBL CLinical Pharmacology Center
Baltimore, Maryland, 21201
California Research Medical Group, INC
Fullerton, California, 92835
Gulf Coast Research, LLC
Lafayette, Louisiana, 70503
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
Dedicated Phase I
Phoenix, Arizona, 85013
Vita Research Solutions & Medical Center, Inc.
Tamarac, Florida, 33319
Florida Pulmonary Research Institue, LLC
Winter Park, Florida, 32789
About this study
Official title: A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-center dose escalation study in subjects diagnosed with stable moderate to severe COPD. The study will be conducted in approximately 6 Clinical Research Units (CRUs).
Subjects with a diagnosis of stable moderate to severe COPD will be screened and must demonstrate an improvement in FEV1 after bronchodilator treatment of at least 12% at Screen Visit 1. The subject's degree of dyspnea will be captured on the British Medical Research Council (MRC) questionnaire, and severity will be determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric criteria. Subjects meeting entry criteria at Screen Visit 1 will be asked to return to the CRU for Screen Visit 2 within 14 days of Visit 1. Subjects confirming entry criteria including degree of COPD severity by spirometry at Screen Visit 2 will be randomized to receive either MN-221 or placebo. Serial spirometry will be performed over the 8 hour treatment period after initiation of study drug administration. Subjects will be discharged from the CRU after completing the Hour 8 study procedures and asked to return approximately 24 hours after initiation of study drug for follow up safety assessments including spirometry. A study diary will be provided to each subject upon discharge from the CRU to complete as instructed and return it to the site at the 24 hour Follow-up Visit.
There will be three dose levels and each will include approximately 16 subjects randomized to receive either MN-221 or placebo in 3:1 ratio (12 subjects receive MN-221:4 subjects receive placebo). A risk/benefit evaluation will be performed by the study's Safety Review Committee at completion of each dose level prior to escalating to the next dose level.
Safety and efficacy will be monitored throughout the treatment period. Blood samples for PK parameters and metabolite identification will be obtained.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MN-221 (Dose Group 1), MN-221 (Dose Group 2), MN-221 (Dose Group 3)
- Keywords
- COPD
- 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-221 (Dose Group 1)Drug
i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour
MN-221 (Dose Group 2)Drug
i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour
MN-221 (Dose Group 3)Drug
i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| MN-221 | Experimental | Not described Receives: Drug: MN-221 (Dose Group 1); Drug: MN-221 (Dose Group 2); Drug: MN-221 (Dose Group 3) |
| MN-221 Placebo | Placebo comparator | Not described Receives: Drug: MN-221 (Dose Group 1); Drug: MN-221 (Dose Group 2); Drug: MN-221 (Dose Group 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.
Measured: Hour 0 (treatment) through Hour 24 (follow-up)
Secondary outcomes (2)
Pharmacokinetic parameters of MN-221.
Measured: Pre-dose to Hour 24 post-dose
Forced expiratory volume in one second (FEV1).
Measured: Pre-dose to Hour 24 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan W Dunton, MD, Study director, MediciNova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013142
- Sponsor's protocol ID
- MN-221-CL-010
- Status last verified
- May 2015
- First submitted
- 10 Nov 2009
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01013142
- Acronym / sponsor ID
- MN-221-CL-010
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Nov 2009 (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.
The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-center dose escalation study in subjects diagnosed with stable moderate to severe COPD. The study will be conducted in approximately 6 Clinical Research Units (CRUs).
Subjects with a diagnosis of stable moderate to severe COPD will be screened and must demonstrate an improvement in FEV1 after bronchodilator treatment of at least 12% at Screen Visit 1. The subject's degree of dyspnea will be captured on the British Medical Research Council (MRC) questionnaire, and severity will be determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric criteria. Subjects meeting entry criteria at Screen Visit 1 will be asked to return to the CRU for Screen Visit 2 within 14 days of Visit 1. Subjects confirming entry criteria including degree of COPD severity by spirometry at Screen Visit 2 will be randomized to receive either MN-221 or placebo. Serial spirometry will be performed over the 8 hour treatment period after initiation of study drug administration. Subjects will be discharged from the CRU after completing the Hour 8 study procedures and asked to return approximately 24 hours after initiation of study drug for follow up safety assessments including spirometry. A study diary will be provided to each subject upon discharge from the CRU to complete as instructed and return it to the site at the 24 hour Follow-up Visit.
There will be three dose levels and each will include approximately 16 subjects randomized to receive either MN-221 or placebo in 3:1 ratio (12 subjects receive MN-221:4 subjects receive placebo). A risk/benefit evaluation will be performed by the study's Safety Review Committee at completion of each dose level prior to escalating to the next dose level.
Safety and efficacy will be monitored throughout the treatment period. Blood samples for PK parameters and metabolite identification will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MN-221 | Experimental | Drug: MN-221 (Dose Group 1), Drug: MN-221 (Dose Group 2), Drug: MN-221 (Dose Group 3) |
| MN-221 Placebo | Placebo comparator | Drug: MN-221 (Dose Group 1), Drug: MN-221 (Dose Group 2), Drug: MN-221 (Dose Group 3) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 40-65 years of age, inclusive;
- History of physician-diagnosed COPD treated for ≥ 3 months ;
- FEV1 ≥ 30% < 80% and FEV1/FVC ratio < 0.7 at screening;
- An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol;
- 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);
Key exclusion criteria (16 listed)
- Beta agonist and/or anticholinergic via inhaler or intravenously ≤ 6 hours of screening;
- Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 24 hours prior to screening;
- A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema;
- Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 90 days of screening;
- Antibiotic therapy for respiratory infection ≤ 30 days of screening;
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-221 (Dose Group 1)i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour | Drug | MN-221, MN-221 Placebo |
| MN-221 (Dose Group 2)i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour | Drug | MN-221, MN-221 Placebo |
| MN-221 (Dose Group 3)i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour | Drug | MN-221, MN-221 Placebo |
Primary outcome
Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.
Time frame: Hour 0 (treatment) through Hour 24 (follow-up)
2 secondary outcomes
Pharmacokinetic parameters of MN-221.
Time frame: Pre-dose to Hour 24 post-dose
Forced expiratory volume in one second (FEV1).
Time frame: Pre-dose to Hour 24 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 May 2015.
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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.
Alan W Dunton, MD study director
MediciNova
7 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 (Dose Group 1), MN-221 (Dose Group 2) and MN-221 (Dose Group 3) in people with Chronic Obstructive Pulmonary Disease, run by MediciNova at 7 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 16 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments. (time frame: Hour 0 (treatment) through Hour 24 (follow-up)). 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 May 2015.