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

NCT ID: NCT00404261

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

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.

Detailed Description

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Conditions

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Asthma

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Fluticasone/Salmeterol HFA MDI without counter

Group Type OTHER

Fluticasone/Salmeterol HFA

Intervention Type DRUG

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Arm 2

Fluticasone/Salmeterol HFA MDI with counter

Group Type OTHER

Fluticasone/Salmeterol HFA

Intervention Type DRUG

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Interventions

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Fluticasone/Salmeterol HFA

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Auchenflower, Queensland, Australia

Site Status

GSK Investigational Site

Caboolture, Queensland, Australia

Site Status

GSK Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

GSK Investigational Site

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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108835

Identifier Type: -

Identifier Source: org_study_id