Clinical trial NCT02905227: A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
Official title: A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Adult smokers
Asthma
Healthy volunteers
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.

Detailed description: The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in measure of pulmonary function via Spirometry
timeFrame: within 1 hour prior to dose and up to 24 hours post-dose.
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: up to 24 hours post-dose.
measure: Maximum observed plasma drug concentration (tmax)
timeFrame: up to 24 hours post-dose.
measure: Area under the concentration time curve over the dosing interval (AUC0-last)
timeFrame: up to 24 hours post-dose.
Secondary outcomes:
measure: Number of subjects with Adverse Events (AEs) including Serious AEs
timeFrame: up to 5 days
Other outcomes:
Locations:
city: North Dartmouth
country: United States
facility: Site #103
state: Massachusetts
city: Lincoln
country: United States
facility: Site #102
state: Nebraska
city: Dallas
country: United States
facility: Site #101
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Charles Oh, MD
role: STUDY_DIRECTOR
References: