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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130351
• Other study ID #: CFOR258F2309
• Status: Completed
• Phase: Phase 3
• Start date: July 2005
• Est. completion date: August 2005

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• formoterol

Locations

Country	Name	City	State
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Colorado Allergy and Asthma Centers, PC	Englewood	Colorado
United States	Allergy and Asthma Specialists Medical Group and Research Ct	Huntington Beach	California
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Northeast Medical Research Associates, Inc	North Dartmouth	Massachusetts
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	The Asthma & Allergy Center, PC	Papillion	Nebraska
United States	Allergy Associates Research Center	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	The Clinical Research Center	Saint Louis	Missouri
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

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Primary	Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.