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

Study Overview
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Brief Summary
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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
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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
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Asthma

Intervention / Treatment
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* Drug: Fluticasone/Salmeterol HFA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Fluticasone/Salmeterol HFA MDI without counter | Drug: Fluticasone/Salmeterol HFA<br>* Fluticasone/Salmeterol HFA, 2 puffs twice daily<br>|
| Other: Arm 2<br>Fluticasone/Salmeterol HFA MDI with counter | Drug: Fluticasone/Salmeterol HFA<br>* Fluticasone/Salmeterol HFA, 2 puffs twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30). |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)