Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
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...
Brief Summary
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.”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: Fluticasone/Salmeterol HFA
Outcome Measures for this Clinical Trial
Primary Measures
- Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404261
Study ID Number: 108835
ClinicalTrials.gov Identifier: NCT00404261
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00404261
