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AsthmaPhase 2NCT00679263

Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma

A Phase 2 study testing MN-221 in people with Asthma, run by MediciNova at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma. Read more about this study

Who is it for?
Ages 18 to 50 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
17 participants
Where
4 sitesUnited States
Study dates
Feb 2008to Jul 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female subjects;
  • Must sign an informed consent;
  • Diagnosis of asthma as defined by the American Thoracic Society for at least 3 months;
  • Must not be receiving inhaled corticosteroids for control within 1 month of study;
  • Must have an increase in FEV1 of at least 12% and 200 cc over the pre-albuterol FEV1 within 30 minutes after inhalation of up to 4 puffs of albuterol via a metered dose inhaler;
  • Non-smoker for at least 6 months and in good health;
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  • Female subjects must have a negative pregnancy test;
  • Male and female subjects of child-bearing potential (not surgically sterile or post menopausal) must be abstinent or agree to use contraceptive regimens throughout the study;
  • Subjects receiving allergy desensitization therapy can participate as long as they have been on a stable maintenance dose for ≥ 6 months;
  • Subject must be willing and able not to use inhaled bronchodilators for 6 hours before and until 24 hours after each study drug administration at all study visits; and
  • Subject must demonstrate mental and physical ability and willingness to follow all study-specific instructions pertaining to the scheduling of study visits and assessments.

Who cannot join

  • Have significant cardiopulmonary, renal, hepatic, endocrine, metabolic, neurological or other systemic disease;
  • Received emergency treatment for asthma within 1 month, or hospitalized for asthma within 3 months;
  • Had an upper or lower respiratory tract infection within 3 weeks, or sinus infection within 7 days;
  • Have participated in a clinical study with an investigational drug, other than an MN-221 study, within 30 days;
  • Have history or evidence of drug or alcohol abuse within 2 years of study entry;
  • Female subjects who are pregnant or lactating;
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  • Taking any of the following excluded asthma/allergy medications within the time periods indicated prior to the first study visit:
  • Oral, inhaled, or parenteral corticosteroids for 1 month prior to the first study visit.
  • Anti-IgE medication for 3 months prior to the first study visit.
  • Theophylline, long-acting bronchodilators, and anti-cholinergics for 2 weeks prior to the first study visit.
  • Taking leukotriene modifiers and not on a stable daily dosage for 4 weeks prior to the first study visit.
  • Taking antihistamines, nasal corticosteroids, or decongestants and not on a stable dose for 3 days prior to any dosing day.
  • Have a known allergy to MN-221 or any of the other components of the study drug (i.e. lactose);
  • Have a history of frequent episodes of orthostatic hypotension or any predisposition for orthostatic hypotension;
  • Have used any prescription or over-the-counter medication, vitamin or herbal supplement (except as listed in Inclusion Criterion 7 and Exclusion Criterion 7-10) within 7 days of study entry, or the expected need to use any unapproved prescription or over-the-counter medication or supplement seven days prior to the first study visit until completion of the study;
  • Taking any drugs or substances known to be strong inhibitors of cytochrome P450 enzymes within 10 days of study entry, or the expected need to use such drugs ten days prior to the first study visit until after completion of the study;
  • Taking any drugs or substances known to be strong inducers of cytochrome P450 enzymes within 28 days of study entry, or the expected need to use such drugs prior to completion of the study;
  • Adhering to any special diet that is not well balanced within 28 days of study entry;
  • Have donated (standard donation amount or more) blood or blood products (with the exception of plasma noted below) within 56 days of study entry;
  • Have donated plasma within 7 days of study entry;
  • Have any laboratory value outside the laboratory reference range that is considered to be clinically significant;
  • Have any abnormal vital signs (B/P, respiratory rate, heart rate) considered to be clinically significant;
  • Have positive results for drug and/or alcohol screen;
  • Have any clinically significant ECG abnormality, including a corrected QT interval (QTc) > 450 msec; and/or
  • Have any other medical condition or reason that, in the Investigator's opinion, makes the subject unsuitable to participate in this clinical trial.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Greenville Pharmaceutical Research

    Greenville, South Carolina, 29615

  • PRA International

    Lenexa, Kansas, 66219

  • Northeast Medical Research Associates

    North Dartmouth, Massachusetts, 02747

  • Clinical Research of the Ozarks

    Rolla, Missouri, 65401

Other trials in United States

About this study

Official title: A Randomized, Single-blind, Parallel Group, Placebo-controlled, Dose Rate Escalation Study Evaluating the Safety and Effects of MN-221 in Subjects Diagnosed With Moderate to Severe Asthma

The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma.

Read the detailed description

This is a multi-center, randomized, single-blind*, parallel group, placebo-controlled, study with two dosing regimens in subjects diagnosed with moderate to severe asthma using MN-221 or placebo. Subjects will be randomized to receive MN-221 or placebo in a 3:1 ratio, MN-221:placebo. Subjects randomized to receive MN-221 will be dosed with active study drug at both dosing visits, and subjects randomized to the placebo arm will receive placebo at both dosing visits. Approximately 25 subjects diagnosed with moderate to severe asthma who have not received inhaled corticosteroid therapy within one month of Screen Visit 1 will be enrolled and will participate throughout the study.

Initial dose:

  • 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg MN-221 or Placebo)

Subsequent dose:

  • 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg MN-221 or Placebo)

There will be approximately a two to four week period between each dose regimen, during which time a safety review will be performed before proceeding to the next dose level. Subjects will be screened for eligibility and continued eligibility will be determined for each subject prior to administering each dose. After the initiation of the intravenous infusion of MN-221 or placebo, serial spirometry will be measured for approximately 24 hours.

For each dose evaluation period, subjects will be domiciled in the clinical research unit (CRU) for 2 nights, beginning on Day -1, one day before dosing. Determination of continued study eligibility will be made on Day -1 for each dose level. Day 1 will include study drug infusion and approximately a 24-hour observation period into Day 2 to allow safety monitoring, serial spirometry, and serum PK measurements. Subjects will be discharged from the CRU on Day 2. They will return to the CRU approximately 2-4 weeks later to participate in the subsequent dose group.

*This is a "modified" single-blind study in which the subject and Investigator are both blinded regarding the treatment arm.

Conditions
Asthma
Being tested
MN-221, Placebo
Keywords
asthma, randomized, placebo controlled, dose escalation, safety, efficacy, single blind, MN-221
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

    Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg)

  • MN-221Drug

    Subsequent dose: 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg).

  • PlaceboDrug

    Placebo intravenous infusion with dosing volume equivalent to active treatment.

Study groups in NCT00679263
Study groupRoleWhat they receive
MN-221ExperimentalNot described
Receives: Drug: MN-221
PLACEBOPlacebo comparatorPlacebo intravenous infusion with dosing volume equivalent to active treatment.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Reported to Have Adverse Events

    Measured: Day 1 to Day 2

Secondary outcomes (1)

  1. FEV1 Percent Predicted Changes From Base Line

    The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.

    Measured: Day 1 to Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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
Single blind
Who is masked
Participant
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679263
Sponsor's protocol ID
MN-221-CL-005
Status last verified
Nov 2011
First submitted
14 May 2008
Last updated
19 Dec 2011
Data monitoring committee
No

Publications

  • Matsuda K, Makhay M, Johnson K, Iwaki Y. Evaluation of bedoradrine sulfate (MN-221), a novel, highly selective beta2-adrenergic receptor agonist for the treatment of asthma via intravenous infusion. J Asthma. 2012 Dec;49(10):1071-8. doi: 10.3109/02770903.2012.729631. Epub 2012 Oct 25.

    PubMed 23094708

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 4 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 11 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 15 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Patients Reported to Have Adverse Events (time frame: Day 1 to Day 2). 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 NCT00679263, which also lists 1 linked publication.

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 19 Dec 2011.

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