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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.
Pacira Pharmaceuticals, Inc
Information provided by:
Novartis Identifier:
First received: August 8, 2005
Last updated: October 24, 2011
Last verified: October 2011
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
Device: formoterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Resource links provided by NLM:

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.

Enrollment: 155
Study Start Date: July 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00130351

United States, California
Allergy and Asthma Specialists Medical Group and Research Ct
Huntington Beach, California, United States, 92647
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
United States, Colorado
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
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
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
The Clinical Research Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Oregon
Allergy Associates Research Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information Identifier: NCT00130351     History of Changes
Other Study ID Numbers: CFOR258F2309
Study First Received: August 8, 2005
Last Updated: October 24, 2011

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017