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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404261

Enrollment

132

Registered

2006-11-28

Start date

2007-01-31

Completion date

2007-08-31

Last updated

2012-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)

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.

Interventions

DRUGFluticasone/Salmeterol HFA

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026