NCT00404261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

November 27, 2006

Last Update Submit

October 17, 2012

Conditions

Asthma

Keywords

Fluticasone Propionatehealthcare professional satisfactionpatient satisfactionmetered dose inhaler with counterSalmeterolChronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

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

    Day 30

Secondary Outcomes (2)

  • 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

  • Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events

    8 months

Study Arms (2)

Arm 1

OTHER

Fluticasone/Salmeterol HFA MDI without counter

Drug: Fluticasone/Salmeterol HFA

Arm 2

OTHER

Fluticasone/Salmeterol HFA MDI with counter

Drug: Fluticasone/Salmeterol HFA

Interventions

Fluticasone/Salmeterol HFADRUG

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Arm 1Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

Location

GSK Investigational Site

Caboolture, Queensland, 4510, Australia

Location

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

AsthmaPatient SatisfactionPulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehaviorChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

January 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

AU(4)