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

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00130351

Run by

Novartis

People needed

155

Starts

2005-07-01

Expected to finish

2005-08-01

Last updated by the study team

2023-05-19

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Allergy and Asthma Specialists Medical Group and Research Ct — Huntington Beach, California, United States
• Allergy and Asthma Medical Group & Research Center — San Diego, California, United States
• Allergy & Asthma Associates of Santa Clara Res. Center — San Jose, California, United States
• Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Englewood, Colorado, United States
• Northeast Medical Research Associates, Inc. — North Dartmouth, Massachusetts, United States
• Northeast Medical Research Associates, Inc — North Dartmouth, Massachusetts, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• The Clinical Research Center — St Louis, Missouri, United States
• The Asthma & Allergy Center, PC — Papillion, Nebraska, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Allergy Associates Research Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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