A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

This is an interventional treatment trial for Migraine focused on measuring Adult smokers, Asthma, Healthy volunteers Read More

Inclusion Criteria:

• eligible subjects will be men or women aged 18 to 65 years inclusive;
• body mass index (BMI) 18 to 30 kg/m2;
• healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
• subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
• subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.

Exclusion Criteria:

• subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
• asthma exacerbation within 8 weeks of before screening;
• unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
• history of intubation or intensive care unit admission for asthma in the past 5 years.
• Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
• any cardiovascular risk factor or contraindication for the use of triptans
• use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or planned use during the study;
• positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] 1 & 2 antibodies).