Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone/Salmeterol HFA

• Registration Number: NCT00404261
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Study Start: 2007-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Fluticasone/Salmeterol HFA	Fluticasone/Salmeterol HFA MDI without counter
Arm 2	Fluticasone/Salmeterol HFA	Fluticasone/Salmeterol HFA MDI with counter

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Perth, Western Australia, Australia