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.

GlaxoSmithKline1 site in 1 country132 target enrollmentJanuary 2007

ConditionsAsthma

InterventionsFluticasone/Salmeterol HFA

DrugsFluticasone/Salmeterol HFA

Overview

Phase: Phase 4
Intervention: Fluticasone/Salmeterol HFA
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 132
Locations: 1
Primary Endpoint: Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

August 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Arm 1

Fluticasone/Salmeterol HFA MDI without counter

Intervention: Fluticasone/Salmeterol HFA

Arm 2

Fluticasone/Salmeterol HFA MDI with counter

Intervention: Fluticasone/Salmeterol HFA

Outcomes

Primary Outcomes

Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).

Time Frame: 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.(Day 30)
Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events(8 months)