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A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
formoterol
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring asthma, formoterol multi-dose dry powder inhaler (MDDPI)

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy and Asthma Specialists Medical Group and Research Ct
  • Allergy and Asthma Medical Group & Research Center
  • Allergy & Asthma Associates of Santa Clara Res. Center
  • Colorado Allergy and Asthma Centers, PC
  • Colorado Allergy and Asthma Centers, PC
  • Northeast Medical Research Associates, Inc.
  • Northeast Medical Research Associates, Inc
  • Clinical Research Institute
  • The Clinical Research Center
  • The Asthma & Allergy Center, PC
  • North Carolina Clinical Research
  • Allergy Associates Research Center

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2005
Last Updated
May 18, 2023
Sponsor
Novartis
Collaborators
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00130351
Brief Title
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Official Title
A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Pacira Pharmaceuticals, Inc

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, formoterol multi-dose dry powder inhaler (MDDPI)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
formoterol
Primary Outcome Measure Information:
Title
Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Title
Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Allergy and Asthma Specialists Medical Group and Research Ct
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Allergy and Asthma Medical Group & Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Res. Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Northeast Medical Research Associates, Inc
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
The Clinical Research Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Asthma & Allergy Center, PC
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

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