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

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ClinicalTrials.gov Identifier: NCT00404261
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : October 18, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone/Salmeterol HFA Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Arm 1
Fluticasone/Salmeterol HFA MDI without counter
Drug: Fluticasone/Salmeterol HFA
Fluticasone/Salmeterol HFA, 2 puffs twice daily

Arm 2
Fluticasone/Salmeterol HFA MDI with counter
Drug: Fluticasone/Salmeterol HFA
Fluticasone/Salmeterol HFA, 2 puffs twice daily




Primary Outcome Measures :
  1. Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30). [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Day 30 ]
  2. Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events [ Time Frame: 8 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404261


Locations
Australia, Queensland
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00404261     History of Changes
Other Study ID Numbers: 108835
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline:
Fluticasone Propionate
healthcare professional satisfaction
patient satisfaction
metered dose inhaler with counter
Salmeterol
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Asthma
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones