Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; COPD
Intervention: Fluticasone/Salmeterol HFA (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MBBS, MPPM, Grad Dip PH, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Centre, Newcastle, New South Wales 23120, Australia
GSK Clinical Trials Call Centre, Kippa Ring, Queensland 4021, Australia
GSK Clinical Trials Call Centre, Perth, Western Australia 6000, Australia
Additional Information
Starting date: December 2006
Ending date: August 2007
Last updated: April 1, 2008
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