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

This study has been completed.

First Received: November 27, 2006 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00404261

Purpose

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.

Condition	Intervention	Phase
Asthma Chronic Obstructive Pulmonary Disease (COPD)	Drug: Fluticasone/Salmeterol HFA	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	132
Study Start Date:	January 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404261

Locations

Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia, 6000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108835
Study First Received:	November 27, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00404261 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Salmeterol
Fluticasone Propionate
metered dose inhaler with counter
patient satisfaction
healthcare professional satisfaction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Therapeutic Uses

Fluticasone
Dermatologic Agents
Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Respiration Disorders
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009