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).
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2007-09-08
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
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Status
Study Complete
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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