Back to resultsEvaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Fluticasone/Salmeterol HFA
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- Outpatient
- Documented physician diagnosis of asthma or COPD
- Requires use of a controller and long acting beta 2 agonist
- Ability to provided written informed consent
Exclusion Criteria:
- Patients with life threatening asthma or COPD
- Historical or current evidence of significant diseases
- Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation
- History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD
- Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm 1
Arm 2
Arm Description
Fluticasone/Salmeterol HFA MDI without counter
Fluticasone/Salmeterol HFA MDI with counter
Outcomes
Primary Outcome Measures
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Secondary Outcome Measures
Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.
Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404261
Brief Title
Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
Official Title
An Open Label, Multicentre Study to Evaluate Patient Satisfaction With Fluticasone/Salmeterol HFA MDI With Counter in Adult Subjects (18 Years of Age and Older) With Asthma or COPD.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA MDI without counter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Fluticasone/Salmeterol HFA MDI without counter
Arm Title
Arm 2
Arm Type
Other
Arm Description
Fluticasone/Salmeterol HFA MDI with counter
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol HFA
Intervention Description
Fluticasone/Salmeterol HFA, 2 puffs twice daily
Primary Outcome Measure Information:
Title
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.
Time Frame
Day 30
Title
Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatient
Documented physician diagnosis of asthma or COPD
Requires use of a controller and long acting beta 2 agonist
Ability to provided written informed consent
Exclusion Criteria:
Patients with life threatening asthma or COPD
Historical or current evidence of significant diseases
Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation
History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD
Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
GSK Investigational Site
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
12. IPD Sharing Statement
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Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
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