AsthmaPhase 2NCT00838591
Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of Asthma
A Phase 2 study testing MN-221 in people with Asthma, run by MediciNova at 15 sites in United States.
Trial summary
The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- 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
- 176 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2009to Mar 2012
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Male or female 18 to 65 years of age, inclusive;
- Self-reported history of physician-diagnosed and treated asthma for ≥ 3 months prior to randomization;
- A diagnosis of an acute exacerbation of asthma upon presentation at the ED as defined by dyspnea and evidence of bronchospasm;
- Received the following Standardized Treatment within a 2-hour time window and prior to obtaining the Qualifying Spirometry value(FEV1):
- Supplemental oxygen given to maintain oxygen saturation as measured by pulse oximetry of ≥ 90% as needed;
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- Albuterol 5-15mg of albuterol via nebulizer prior to the qualifying spirometry evaluation; simultaneously with
- Ipratropium 0.5-1.5 mg of ipratropium via nebulizer prior to the qualifying spirometry evaluation;
- One dose of corticosteroid of at least 50 mg given orally (prednisone) or intravenously (methylprednisolone) or the equivalent dose of another corticosteroid.
- FEV1 of ≤ 50% of predicted; NOTE: Spirometry to measure the subject's FEV1 expressed as % of predicted within 30 minutes of completing administration of 5 mg (but not more than 15 mg) albuterol and 0.5 mg (but not more than 1.5 mg) of ipratropium..
- Negative urine pregnancy test for all females of child-bearing potential;
- ECG with no dysrhythmias (except sinus tachycardia);
- No clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator; and
- Legally effective written informed consent obtained prior to starting any mandated study procedures
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Administration of a parenteral (intravenous or subcutaneous) beta agonist (e. g., albuterol, terbutaline, epinephrine) within 6 hours prior to randomization;
- A current or prior diagnosis or suspected diagnosis of COPD or other chronic lung disease other than asthma;
- Presence of pneumonia;
- Presence of significant other respiratory dysfunction such as pneumothorax, pneumomediastinum, or pulmonary edema;
- Known or suspected vocal cord dysfunction syndrome;
Show all 25Show fewer
- Presence of aspirated foreign body (known or suspected);
- History or any current clinical evidence suggesting cardiomyopathy or congestive heart failure;
- History or presence of tachyarrhythmias, with the exception of sinus tachycardia;
- Heart rate ≥ 140 bpm;
- Hypokalemia, defined as subjects with serum potassium level of <2.8 mEq/L (≤2.8 mmol/L) obtained at Screening (local stat lab, blood gas analysis, or other point of care device) with the following exception:
- For the subjects using non-potassium-sparing diuretics (i.e. loop-diuretic or thiazide diuretic) without "potassium-sparing diuretics" (e.g., Triamterene or Spironolactone) OR without potassium supplementation of at least KCl 20 mEq/day whose potassium level <3.5 mEq/L (<3.5 mmol/L) at Screening.
- Significant cardiac, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease will be defined as one which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study or the subject's ability to participate in the trial;
- Self-reported history of greater than 20 pack-yr smoking history;
- Fever ≥ 102.0 ºF (38.9 ºC);
- Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg (22.7/13.3 kPa);
- Need for immediate intubation, mechanical ventilation, or non-invasive positive pressure ventilation as determined by the Investigator;
- Pregnant or lactating females;
- Participated in another clinical study with an investigational drug within 30 days of randomization;
- Positive urine drug screen for cocaine, methamphetamine or PCP unless, in the Investigator's clinical judgment, a single positive result is explained by exposure to a non-illicit drug product (i.e., is a false positive). For example, phenylpropanolamine or methylphenidate may read positive in a methamphetamine screen; dextromethorphan in a PCP screen.
- Any subject with a known allergy to components of the MN-221 drug product;
- Any subject with a known allergy to other beta agonists;
- Previous exposure to MN-221; or
- Use of theophylline, beta blockers, digoxin, MAO inhibitors, or tricyclic antidepressants within 2 weeks prior to randomization.
- Use of non-potassium-sparing diuretics (i.e. Thiazide or Loop-diuretic) without potassium-sparing diuretic OR without potassium supplementation >20 mEq/day within 2 weeks prior to randomization and if serum potassium level at Screening <3.5 mEq/L (<3.5 mmol/L).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Cincinnati
Cincinnati, Ohio, 45267-0563
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Loma Linda University Medical Center
Loma Linda, California, 92354
Loyola University Medical Center
Maywood, Illinois, 60153
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Newton - Wellesley Hospital
Newton, Massachusetts, 02462
Sentara General Hospital
Norfolk, Virginia, 23507
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Rhode Island Hospital
Providence, Rhode Island, 02903
UCSD Medical Center - Thornton Hospital
San Diego, California, 92037
UCSD Medical Center
San Diego, California, 92103
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University School of Medicine
St Louis, Missouri, 63110
Olive View - UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: MN-221-CL-007: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma
The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma.
Read the detailed description
This is an international, randomized, double-blind, placebo-controlled, multi-center ED study. Each subject will receive MN-221 or placebo administered through a continuous intravenous infusion in addition to the standardized treatment for an acute exacerbation of asthma.
Upon presentation to the ED for assessment and treatment for an acute exacerbation of asthma the patient should receive standard of care consistent with the international guidelines (e.g., Global Initiative for Asthma [GINA] or the National Asthma Education and Prevention Program [NAEPP]) and required, in part, by this protocol prior to screening procedures being performed.
Prior to any study specific treatment or evaluation being performed a subject must have signed an IRB/EC/REB approved consent form. Once the subject has received the initial treatment regimen the subject will be assessed for response to the treatment including spirometry.If the subject meets all entry criteria the subject will be randomized to receive MN-221 or placebo. Throughout the screening process the subject will continue to receive standardized treatment consistent with the appropriate guidelines for the treatment of acute exacerbations of asthma.
Subjects enrolled in the study will receive an intravenous 1-hour infusion of MN-221 study drug or placebo. Subjects receiving MN-221 will be administered a total dose of 1200 μg.
During the study treatment period, the subject may continue to receive standardized treatment and be assessed. The study treatment period will be approximately 3 hours in length. Safety and efficacy will be monitored throughout the treatment period. PK parameters (if applicable) will be obtained from subjects at selected study sites. A blood sample for genomic evaluation will be collected during the treatment period (at participating sites) if the subject consents to the evaluation. An initial 24-hour post-randomization follow-up visit will be completed to evaluate the subject's health status as well as for safety and PK parameters (if applicable). A second follow-up contact will be completed by telephone seven days post-randomization for safety purposes and to evaluate the subject's health status.
A periodic risk/benefit evaluation will be performed by the study's Data Safety Monitoring Board.
- Conditions
- Asthma
- Being tested
- MN-221, Placebo
- Keywords
- MN-221, Asthma, Acute, Exacerbation
- Medical subject headings
- Asthma
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
Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MN-221 given i.v. 1-hour infusion a total dose of 1200 μg (40 μg/min for 15 min [600 μg] + 13.3 μg/min for 45 min [600 μg]) as an adjunct to the standard of care for acute exacerbation of asthma. Receives: Drug: MN-221 |
| Placebo | Placebo comparator | Placebo (Lot #CLO-095) was packaged in identical vials containing only excipients and administered as an i.v. 1-hour infusion with a regimen as described for MN-221. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint.
Measured: Hour 3
Secondary outcomes (15)
Change from baseline FEV1 % of predicted (at time points other than Hour 3)
Measured: Hours 1, 2, 3, and 24
Change from baseline FEV1 (L)
Measured: Hours 1, 2, 3 and 24
Change from baseline PEFR (L/sec)
Measured: Hours 1, 2, 3 and 24
Change from baseline PEFR, expressed as percent (%) of predicted
Measured: Hours 1, 2, 3and 24
Improvement in Dyspnea index scale
Measured: Hours 1, 2, 3, 24 and Day 8
Percent of subjects with an improvement in FEV1 ≥ 200cc
Measured: Hours 1, 2, 3 and 24
Percent of subjects with an improvement in FEV1, % predicted ≥ 5%
Measured: Hours 1, 2, 3 and 24
Percent of subjects with and improvement in FEV1, % predicted ≥ 10%
Measured: Hours 1, 2, 3 and 24
Subjects Hospitalized ( within 24 hour from start of study drug infusion)
Measured: Within 24 hours from start of study drug infusion.
Admitted to ICU (within 24 hours from start of study drug infusion)
Measured: Within 24 hours from start of study drug infusion.
Number of albuterol treatments to achieve an increase in FEV1% of predicted ≥ 15%
Measured: Hours 3
Total dose or number of albuterol treatments in first 3 hours following commencement of randomized medication.
Measured: No specific time points
Time to achieve an increase of FEV1% of predicted ≥ 15%
Measured: No specific time points
Time to initial albuterol treatment following the commencement of randomized medication
Measured: No specific time points
Hospital length of stay
Measured: No specific timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuko Matsuda, MD, Study director, MediciNova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838591
- Sponsor's protocol ID
- MN-221-CL-007
- Status last verified
- Sep 2013
- First submitted
- 5 Feb 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
House SL, Matsuda K, O'Brien G, Makhay M, Iwaki Y, Ferguson I, Lovato LM, Lewis LM. Efficacy of a new intravenous beta2-adrenergic agonist (bedoradrine, MN-221) for patients with an acute exacerbation of asthma. Respir Med. 2015 Oct;109(10):1268-73. doi: 10.1016/j.rmed.2015.08.003. Epub 2015 Aug 14.
PubMed 26324315Schneider JE, Lewis LM, Ferguson I, House SL, Liu J, Matsuda K, Johnson K. Repeated dyspnea score and percent FEV1 are modest predictors of hospitalization/relapse in patients with acute asthma exacerbation. Respir Med. 2014 Sep;108(9):1284-91. doi: 10.1016/j.rmed.2014.06.006. Epub 2014 Jul 8.
PubMed 25087835
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MN-221-CL-007: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma
- ClinicalTrials.gov ID
- NCT00838591
- Acronym / sponsor ID
- MN-221-CL-007
- Conditions
- Asthma
- Keywords
- MN-221, Asthma, Acute, Exacerbation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Feb 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 examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma.
Detailed description
This is an international, randomized, double-blind, placebo-controlled, multi-center ED study. Each subject will receive MN-221 or placebo administered through a continuous intravenous infusion in addition to the standardized treatment for an acute exacerbation of asthma.
Upon presentation to the ED for assessment and treatment for an acute exacerbation of asthma the patient should receive standard of care consistent with the international guidelines (e.g., Global Initiative for Asthma [GINA] or the National Asthma Education and Prevention Program [NAEPP]) and required, in part, by this protocol prior to screening procedures being performed.
Prior to any study specific treatment or evaluation being performed a subject must have signed an IRB/EC/REB approved consent form. Once the subject has received the initial treatment regimen the subject will be assessed for response to the treatment including spirometry.If the subject meets all entry criteria the subject will be randomized to receive MN-221 or placebo. Throughout the screening process the subject will continue to receive standardized treatment consistent with the appropriate guidelines for the treatment of acute exacerbations of asthma.
Subjects enrolled in the study will receive an intravenous 1-hour infusion of MN-221 study drug or placebo. Subjects receiving MN-221 will be administered a total dose of 1200 μg.
During the study treatment period, the subject may continue to receive standardized treatment and be assessed. The study treatment period will be approximately 3 hours in length. Safety and efficacy will be monitored throughout the treatment period. PK parameters (if applicable) will be obtained from subjects at selected study sites. A blood sample for genomic evaluation will be collected during the treatment period (at participating sites) if the subject consents to the evaluation. An initial 24-hour post-randomization follow-up visit will be completed to evaluate the subject's health status as well as for safety and PK parameters (if applicable). A second follow-up contact will be completed by telephone seven days post-randomization for safety purposes and to evaluate the subject's health status.
A periodic risk/benefit evaluation will be performed by the study's Data Safety Monitoring Board.
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 |
|---|---|---|
| 1 | Experimental | Drug: MN-221MN-221 given i.v. 1-hour infusion a total dose of 1200 μg (40 μg/min for 15 min [600 μg] + 13.3 μg/min for 45 min [600 μg]) as an adjunct to the standard of care for acute exacerbation of asthma. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Lot #CLO-095) was packaged in identical vials containing only excipients and administered as an i.v. 1-hour infusion with a regimen as described for MN-221. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects meeting all of the following criteria will be considered for admission to the study:
Key exclusion criteria (25 listed)
- Administration of a parenteral (intravenous or subcutaneous) beta agonist (e. g., albuterol, terbutaline, epinephrine) within 6 hours prior to randomization;
- A current or prior diagnosis or suspected diagnosis of COPD or other chronic lung disease other than asthma;
- Presence of pneumonia;
- Presence of significant other respiratory dysfunction such as pneumothorax, pneumomediastinum, or pulmonary edema;
- Known or suspected vocal cord dysfunction syndrome;
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 sulfateDose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo. | Drug | 1 |
| Placebo | Drug | Placebo |
Primary outcome
The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint.
Time frame: Hour 3
15 secondary outcomes
Change from baseline FEV1 % of predicted (at time points other than Hour 3)
Time frame: Hours 1, 2, 3, and 24
Change from baseline FEV1 (L)
Time frame: Hours 1, 2, 3 and 24
Change from baseline PEFR (L/sec)
Time frame: Hours 1, 2, 3 and 24
Change from baseline PEFR, expressed as percent (%) of predicted
Time frame: Hours 1, 2, 3and 24
Improvement in Dyspnea index scale
Time frame: Hours 1, 2, 3, 24 and Day 8
Percent of subjects with an improvement in FEV1 ≥ 200cc
Time frame: Hours 1, 2, 3 and 24
Percent of subjects with an improvement in FEV1, % predicted ≥ 5%
Time frame: Hours 1, 2, 3 and 24
Percent of subjects with and improvement in FEV1, % predicted ≥ 10%
Time frame: Hours 1, 2, 3 and 24
Subjects Hospitalized ( within 24 hour from start of study drug infusion)
Time frame: Within 24 hours from start of study drug infusion.
Admitted to ICU (within 24 hours from start of study drug infusion)
Time frame: Within 24 hours from start of study drug infusion.
Number of albuterol treatments to achieve an increase in FEV1% of predicted ≥ 15%
Time frame: Hours 3
Total dose or number of albuterol treatments in first 3 hours following commencement of randomized medication.
Time frame: No specific time points
Time to achieve an increase of FEV1% of predicted ≥ 15%
Time frame: No specific time points
Time to initial albuterol treatment following the commencement of randomized medication
Time frame: No specific time points
Hospital length of stay
Time frame: No specific timepoints
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 5 Sep 2013.
- Derived from this study: PubMed 26324315House SL, Matsuda K, O'Brien G, Makhay M, Iwaki Y, Ferguson I, Lovato LM, Lewis LM. Efficacy of a new intravenous beta2-adrenergic agonist (bedoradrine, MN-221) for patients with an acute exacerbation of asthma. Respir Med. 2015 Oct;109(10):1268-73. doi: 10.1016/j.rmed.2015.08.003. Epub 2015 Aug 14.
- Derived from this study: PubMed 25087835Schneider JE, Lewis LM, Ferguson I, House SL, Liu J, Matsuda K, Johnson K. Repeated dyspnea score and percent FEV1 are modest predictors of hospitalization/relapse in patients with acute asthma exacerbation. Respir Med. 2014 Sep;108(9):1284-91. doi: 10.1016/j.rmed.2014.06.006. Epub 2014 Jul 8.
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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.
Kazuko Matsuda, MD study director
MediciNova
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MN-221 in people with Asthma, run by MediciNova at 15 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 14 inclusion and 25 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint. (time frame: Hour 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838591, which also lists 2 linked publications.
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 5 Sep 2013.