Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00130351
First received: August 8, 2005
Last updated: October 24, 2011
Last verified: October 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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)
  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
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 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 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
Novartis
Pacira Pharmaceuticals, Inc
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130351     History of Changes
Other Study ID Numbers: CFOR258F2309
Study First Received: August 8, 2005
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014