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:
Novartis
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
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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
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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012
