Clinical trial NCT00130351: A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Official title: A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma, formoterol multi-dose dry powder inhaler (MDDPI)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2005-08-15
Enrollment: 155
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
measure: Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group and Research Ct
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group & Research Center
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Res. Center
state: California
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Englewood
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Saint Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Papillion
country: United States
facility: The Asthma & Allergy Center, PC
state: Nebraska
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: