A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
1 other identifier
interventional
155
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Jul 2005
Shorter than P25 for phase_3 asthma
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 15, 2005
CompletedMay 19, 2023
October 1, 2011
1 month
August 8, 2005
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Pacira Pharmaceuticals, Inccollaborator
Study Sites (12)
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, 92647, United States
Allergy and Asthma Medical Group & Research Center
San Diego, California, 92123, United States
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, 95117, United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230, United States
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, 80112, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
The Asthma & Allergy Center, PC
Papillion, Nebraska, 68046, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 15, 2005
Study Start
July 1, 2005
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
May 19, 2023
Record last verified: 2011-10