AsthmaPhase 4NCT00404261
Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
A Phase 4 study testing Fluticasone/Salmeterol HFA in people with Asthma, run by GlaxoSmithKline at 4 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone/Salmeterol HFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesAustralia
- Study dates
- Jan 2007to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Australia4 sites
GSK Investigational Site
Auchenflower, Queensland, 4066
GSK Investigational Site
Caboolture, Queensland, 4510
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Perth, Western Australia, 6000
About this study
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.
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.
- Conditions
- Asthma
- Being tested
- Fluticasone/Salmeterol HFA
- Keywords
- Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Asthma, Patient Satisfaction, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone/Salmeterol HFADrug
Fluticasone/Salmeterol HFA, 2 puffs twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Fluticasone/Salmeterol HFA MDI without counter Receives: Drug: Fluticasone/Salmeterol HFA |
| Arm 2 | Other | Fluticasone/Salmeterol HFA MDI with counter Receives: Drug: Fluticasone/Salmeterol HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Measured: 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.
Measured: Day 30
Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404261
- Sponsor's protocol ID
- 108835
- Status last verified
- Oct 2012
- First submitted
- 27 Nov 2006
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00404261
- Acronym / sponsor ID
- 108835
- Conditions
- Asthma
- Keywords
- Fluticasone Propionate, healthcare professional satisfaction, patient satisfaction, metered dose inhaler with counter, Salmeterol, Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Fluticasone/Salmeterol HFAFluticasone/Salmeterol HFA MDI without counter |
| Arm 2 | Other | Drug: Fluticasone/Salmeterol HFAFluticasone/Salmeterol HFA MDI with counter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone/Salmeterol HFAFluticasone/Salmeterol HFA, 2 puffs twice daily | Drug | Arm 1, Arm 2 |
Primary outcome
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
Time frame: Day 30
2 secondary outcomes
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
Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone/Salmeterol HFA in people with Asthma, run by GlaxoSmithKline at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30). (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.