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

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