Status:
COMPLETED
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Lead Sponsor:
Novartis
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Asthma
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00130351
Start Date
July 1 2005
End Date
August 1 2005
Last Update
May 19 2023
Active Locations (12)
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1
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, United States, 92647
2
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
3
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, United States, 95117
4
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230