clinical Trials - asthma

Moderate to severe asthma treated with novel anti-inflammatory:

This clinical trial is designed for patients with mild to moderate asthma. Treatment is with a novel anti-inflammatory drug known as MN-001 (tipelukast). For more information about this trial, click here. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Male or female 18 to 65 years of age, inclusive.
Legally effective written informed consent is obtained prior to starting any study procedures.
A diagnosis of asthma as defined by the ATS for at least 3 months with a pre-bronchodilator FEV1 > 65% or predicted at the Screening Visit.
An increase in FEV1 of at least 0.2 L and > 12% after up to 4 puffs of albuterol.
A total symptom score of at least 24 and at least 21 actuations of albuterol in the 14-day placebo run-in period.
Non-smoker for at least 6 months (10 pack-year history maximum allowed) and in good health, except for asthma.
Negative serum pregnancy test at the Screening visit and negative urine pregnancy test at Visit 3 for all females.
Males and females of child-bearing potential must be abstinent or agree to use one of the following contraceptive regimens throughout the study:

Systemic contraceptive
Diaphragm with spermicide
Cervical cap
Intrauterine device
Condom with spermicide

Subjects receiving allergy desensitization therapy can participate as long as the subject has been on a stable maintenance dose for > 3 months prior to the Screening Visit.
Normal ECG, vital signs and laboratory values during the Screening, or results that are judged as Not Clinically Significant by the investigator.

The following criteria would exclude a patient from this trial:

Anyone previously enrolled in a clinical trail of MN-001.
Significant cardiopulmonary, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease.
Received emergency treatment for asthma within 1 month, or hospitalized for asthma within 3 months of the Screening Visit.
An upper or lower respiratory tract infection within 3 weeks, or sinus infection within 7 days of the Screening Visit.
Participated in another clinical study with an investigational drug within 30 days of the Screening Visit.
A history or evidence of drug or alcohol abuse.
Female patients who are pregnant, lactating, or are likely to become pregnant during the study.
Taking any of the excluded medications as follows:

Oral, inhaled, or Parenteral corticosteroids, for 1 month prior to the Screening Visit and throughout the study.
Anti-IgE medications for 3 months prior to the Screening Visit and throughout the study.
Non-steroids for 1 month prior to the Screening Visit and throughout study. This could include leukotriene modifiers, theophylline, etc.
Beta blockers within 14 days of Screening Visit.

A patient with a known allergy to MN-001, MN-002 or any of the other components of the study tablets.