A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
This study is designed to investigate the ability of patients with asthma to properly use a
 new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.
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