A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Asthma

About this trial
This is an interventional other trial for Asthma focused on measuring asthma, formoterol multi-dose dry powder inhaler (MDDPI)
Eligibility Criteria
Inclusion Criteria: Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary Patients who have a current diagnosis of asthma Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry. Exclusion Criteria: Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device. QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies Other protocol-defined inclusion and exclusion criteria apply
Sites / Locations
- Allergy and Asthma Specialists Medical Group and Research Ct
- Allergy and Asthma Medical Group & Research Center
- Allergy & Asthma Associates of Santa Clara Res. Center
- Colorado Allergy and Asthma Centers, PC
- Colorado Allergy and Asthma Centers, PC
- Northeast Medical Research Associates, Inc.
- Northeast Medical Research Associates, Inc
- Clinical Research Institute
- The Clinical Research Center
- The Asthma & Allergy Center, PC
- North Carolina Clinical Research
- Allergy Associates Research Center