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

Tracking Information

First Received Date ^ICMJE

November 27, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00404261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Asthma
Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: Fluticasone/Salmeterol HFA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

132

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00404261

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

108835

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP