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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00679263
• Date of registration: 14/05/2008
• Primary sponsor: MediciNova
• Public title: Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00679263
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael Kalafer
• Affiliation: MediciNova, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subjects;

2. Must sign an informed consent;

3. Diagnosis of asthma as defined by the American Thoracic Society for at least 3
months;

4. Must not be receiving inhaled corticosteroids for control within 1 month of study;

5. 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;

6. Non-smoker for at least 6 months and in good health;

7. Female subjects must have a negative pregnancy test;

8. 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;

9. Subjects receiving allergy desensitization therapy can participate as long as they
have been on a stable maintenance dose for = 6 months;

10. 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

11. Subject must demonstrate mental and physical ability and willingness to follow all
study-specific instructions pertaining to the scheduling of study visits and
assessments.

Exclusion Criteria:

1. Have significant cardiopulmonary, renal, hepatic, endocrine, metabolic, neurological
or other systemic disease;

2. Received emergency treatment for asthma within 1 month, or hospitalized for asthma
within 3 months;

3. Had an upper or lower respiratory tract infection within 3 weeks, or sinus infection
within 7 days;

4. Have participated in a clinical study with an investigational drug, other than an
MN-221 study, within 30 days;

5. Have history or evidence of drug or alcohol abuse within 2 years of study entry;

6. Female subjects who are pregnant or lactating;

7. 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.

8. Taking leukotriene modifiers and not on a stable daily dosage for 4 weeks prior to
the first study visit.

9. Taking antihistamines, nasal corticosteroids, or decongestants and not on a stable
dose for 3 days prior to any dosing day.

10. Have a known allergy to MN-221 or any of the other components of the study drug (i.e.
lactose);

11. Have a history of frequent episodes of orthostatic hypotension or any predisposition
for orthostatic hypotension;

12. 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;

13. 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;

14. 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;

15. Adhering to any special diet that is not well balanced within 28 days of study entry;

16. Have donated (standard donation amount or more) blood or blood products (with the
exception of plasma noted below) within 56 days of study entry;

17. Have donated plasma within 7 days of study entry;

18. Have any laboratory value outside the laboratory reference range that is considered
to be clinically significant;

19. Have any abnormal vital signs (B/P, respiratory rate, heart rate) considered to be
clinically significant;

20. Have positive results for drug and/or alcohol screen;

21. Have any clinically significant ECG abnormality, including a corrected QT interval
(QTc) > 450 msec; and/or

22. Have any other medical condition or reason that, in the Investigator's opinion, makes
the subject unsuitable to participate in this clinical trial.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: MN-221

Drug: Placebo

Primary Outcome(s)

Number of Patients Reported to Have Adverse Events [Time Frame: Day 1 to Day 2]

Secondary Outcome(s)

FEV1 Percent Predicted Changes From Base Line [Time Frame: Day 1 to Day 2]

Secondary ID(s)

MN-221-CL-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors