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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404261
• Other study ID #: 108835
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2006
• Last updated: October 17, 2012
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone/Salmeterol HFA
Fluticasone/Salmeterol HFA, 2 puffs twice daily

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Caboolture	Queensland
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).		Day 30
Secondary	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.		Day 30
Secondary	Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events		8 months