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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fluticasone/Salmeterol HFA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Auchenflower, Queensland 4066, Australia

GSK Investigational Site, Caboolture, Queensland 4510, Australia

GSK Investigational Site, Kippa Ring, Queensland 4021, Australia

GSK Investigational Site, Perth, Western Australia 6000, Australia

Additional Information

Starting date: January 2007
Last updated: October 17, 2012

Page last updated: August 23, 2015

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