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: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: Fluticasone/Salmeterol HFA

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

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

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MBBS, MPPM, Grad Dip PH Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

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