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A 3-Week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
This study has been completed.
Sponsors and Collaborators: Novartis
Pacira Pharmaceuticals, Inc
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00130351
  Purpose

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.


Condition Intervention Phase
Asthma
Device: formoterol
Phase III

MedlinePlus related topics: Asthma
Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A 3-Week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 150
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130351

Locations
United States, California
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, United States, 92647
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, United States, 92647
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, United States, 92647
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, United States, 95117
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, United States, 95117
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, United States, 95117
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Allergy and Asthma Medical Group & Research Center
San Diego, California, United States, 92123
United States, Colorado
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
United States, Massachusetts
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, United States, 02747
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States, 02747
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
The Clinical Research Center
St. Louis, Missouri, United States, 63141
The Clinical Research Center
St. Louis, Missouri, United States, 63141
The Clinical Research Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Oregon
Allergy Associates Research Center
portland, Oregon, United States, 97213
Allergy Associates Research Center
Portland, Oregon, United States, 97213
Allergy Associates Research Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Novartis
Pacira Pharmaceuticals, Inc
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Study ID Numbers: CFOR258F2309
Study First Received: August 8, 2005
Last Updated: October 18, 2006
ClinicalTrials.gov Identifier: NCT00130351  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
asthma, formoterol multi-dose dry powder inhaler (MDDPI)

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Formoterol
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009