Last updated: 11/03/2018 10:07:22

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

GSK study ID
108835
See study documents
Clinicaltrials.gov ID
NCT00404261
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Participant satisfaction questionnaires : How would the participants rate their satisfaction with the MDI provided

Timeframe: Day 30

Participant Satisfaction Questionnaire: Overall, which statement best describes your overall satisfaction between the MDI with counter and the MDI without counter

Timeframe: Day 30

Participant satisfaction questionnaires : How the MDI counter allowed participants to monitor their medication use

Timeframe: Day 30

Secondary outcomes:

Participant satisfaction questionnaires : Did participants feel anxious about the amount of asthma/COPD medication left in their inhaler

Timeframe: Day 30

Participant satisfaction questionnaires: How confident were the participants that they had the number of asthma/COPD puffs or number of days of medication remaining in your inhaler

Timeframe: Day 30

Healthcare professional satisfaction questionnaires : How confident were they that the participant was able to determine how much asthma/COPD medication remained in his/her inhaler

Timeframe: Day 30

Healthcare professional satisfaction questionnaires : How did participants rated their satisfaction with the MDI provided

Timeframe: Day 30

Healthcare professional satisfaction questionnaires : The MDI counter has allowed them to monitor the participant's medication use

Timeframe: Day 30

Participant compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading

Timeframe: Day 30

Number of participants who responded “No” to the question “Have you missed any doses of your inhaler

Timeframe: Day 30

Number of Participants with adverse event (AE) and serious adverse event (SAE)

Timeframe: Up to 8 months

Interventions:
  • Drug: Fluticasone/Salmeterol HFA
    • Enrollment:
    104
    Primary completion date:
    2007-09-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    January 2007 to August 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Outpatient
    • Documented physician diagnosis of asthma or COPD
    • Patients with life threatening asthma or COPD
    • Historical or current evidence of significant diseases
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Perth, Western Australia, Australia, 6000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Caboolture, Queensland, Australia, 4510
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kippa Ring, Queensland, Australia, 4021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Auchenflower, Queensland, Australia, 4066
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-09-08
    Actual study completion date
    2007-09-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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