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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.
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
History of Changes

August 8, 2005
October 24, 2011
July 2005
August 2005   (final data collection date for primary outcome measure)
  • 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.
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Complete list of historical versions of study NCT00130351 on ClinicalTrials.gov Archive Site
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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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Asthma
Device: formoterol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130351
CFOR258F2309
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Not Provided
Novartis
Pacira Pharmaceuticals, Inc
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP