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.

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.

Conditions

• Asthma
• COPD

Study Type

Interventional

Study Design

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

Further Details

• Primary Outcomes: Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
• Secondary Outcomes: 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.

Study Start

December 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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.

Total Enrolment

150

Contact Details

• GSK Clinical Trials Call Centre, Newcastle, New South Wales, 23120, Australia GSK Clinical Trials Call Centre 1-877-379-3718 Peter.Gibson@hnehealth.nsw.gov.au
• GSK Clinical Trials Call Centre, Perth, Western Australia, 6000, Australia GSK Clinical Trials Call Centre 1-877-379-3718 peter@lungs.com.au