Pulmonary Disease, Chronic ObstructivePhase 3NCT01868009
DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing ELLIPTA and DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in United States.
Trial summary
Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- ELLIPTA and DISKUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 17 sitesUnited States
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Informed consent
- Subject must give their signed and dated written informed consent to participate.
- Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
- Subject must be able to read, comprehend, and record information in English.
- 2. Age: >=40 years of age at Visit 1
- 3. Gender: Male or female subjects
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- 4. COPD diagnosis subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
- 5. Severity of disease:
- Subject with a measured post-albuterol Forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) ratio of <=0.70 at Visit 1
- Subjects with a measured post-albuterol FEV1 <=70% of predicted normal values calculated using Third National Health and Nutrition Examination Survey reference equations at Visit 1.
- Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400 micrograms) of albuterol via a metered dose inhaler (MDI) with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated by the investigator site.
- Documented spirometry measurements that meet this criterion in the last 12 months preceding Visit 1 is acceptable.
- 6. Tobacco use: current or former smokers
- Smokers are defined as those who smoke 10 pack-years of cigarette.
- Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
- Number of pack years = (number of cigarettes per day/20) x number of years smoked
Who cannot join
- 1. Previous experience with the DISKUS inhaler
- Subjects who used any DISKUS inhaler (e.g., ADVAIR DISKUS, FLOVENT DISKUS®; participated in a clinical study of fluticasone propionate/salmeterol, or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- 2. Previous experience with the ELLIPTA inhaler
- Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of FF/VI or GSK573719/GW642444 [umeclidinium/vilanterol], or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- 3. Asthma: Subjects with a current diagnosis of asthma.
- Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
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- 4. Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:
- Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician, in the 4 weeks prior to Visit 1.
- Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.
- Use of a total of 8 puffs/day or more of short-acting symptom relief medications such as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days immediately preceding Visit 1.
- Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit 1.
- 5. Other diseases/abnormalities: Subjects with current evidence of uncontrolled or clinically significant disease.
- Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Subjects with suspected or evidence of oropharyngeal candidiasis will be excluded from the study.
- Note: subjects who develop oropharyngeal candidiasis during the study will be treated at the discretion of the investigator.
- 6. Drug/food allergy: Subjects with a history of hypersensitivity to any of the components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded.
- 7. Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse at Visit 1 which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement
- 8. Medication prior to spirometry: Subjects who are medically unable or unwilling to withhold their COPD medications prior to spirometry testing at Visit 1. Subjects, who have documented spirometry measurements that meet the specified Inclusion Criterion in the last 12 months preceding Visit 1, do not have to undergo repeat spirometry at Visit 1.
- 9. Investigational drug or device: Subjects who participated in an interventional study or used any investigational drug or device within 30 days or 5 half lives, whichever is longer, prior to Visit 1
- 10. Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Clearwater, Florida, 33765-2616
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Huntersville, North Carolina, 28078
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Leesburg, Florida, 34748
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Orlando, Florida, 32825
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Seneca, South Carolina, 29678
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99204
About this study
Official title: RLV116669, A Preference Study of Device Attributes Between Two Placebo Dry Powder Inhalers; ELLIPTA and DISKUS, in Adult Subjects With Chronic Obstructive Pulmonary Disease
Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers.
The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity.
The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- ELLIPTA, DISKUS
- Keywords
- fluticasone furoate, COPD, ELLIPTA, fluticasone propionate, DISKUS, Novel Dry Powder Inhaler (NDPI), device preference, salmeterol, vilanterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELLIPTADevice
Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip)
DISKUSDevice
Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip)
| Study group | Role | What they receive |
|---|---|---|
| ELLIPTA Period 1 and DISKUS Period 2 Arm | Experimental | Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period. Receives: Device: ELLIPTA; Device: DISKUS |
| DISKUS Period 1 and ELLIPTA Period 2 Arm | Experimental | Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period. Receives: Device: ELLIPTA; Device: DISKUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.
Measured: up to Study Day 26
Secondary outcomes (2)
Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.
Measured: up to Study Day 26
Number of Participants With the Indicated Device Preference Based on the Size of the Device
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.
Measured: up to Study Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 287 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
- NCT01868009
- Sponsor's protocol ID
- 116669
- Status last verified
- Dec 2013
- First submitted
- 30 May 2013
- Last updated
- 4 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yun Kirby S, Zhu CQ, Kerwin EM, Stanford RH, Georges G. A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA(R) Dry Powder Inhaler (DPI) versus DISKUS(R) DPI. COPD. 2016;13(2):167-75. doi: 10.3109/15412555.2015.1057274. Epub 2015 Oct 30.
PubMed 26516724
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RLV116669, A Preference Study of Device Attributes Between Two Placebo Dry Powder Inhalers; ELLIPTA and DISKUS, in Adult Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01868009
- Acronym / sponsor ID
- 116669
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- fluticasone furoate, COPD, ELLIPTA, fluticasone propionate, DISKUS, Novel Dry Powder Inhaler (NDPI), device preference, salmeterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers.
The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity.
The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELLIPTA Period 1 and DISKUS Period 2 Arm | Experimental | Device: ELLIPTA, Device: DISKUSSubjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period. |
| DISKUS Period 1 and ELLIPTA Period 2 Arm | Experimental | Device: ELLIPTA, Device: DISKUSSubjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Informed consent
- Subject must give their signed and dated written informed consent to participate.
- Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
- Subject must be able to read, comprehend, and record information in English.
- 2. Age: >=40 years of age at Visit 1
Key exclusion criteria (20 listed)
- 1. Previous experience with the DISKUS inhaler
- Subjects who used any DISKUS inhaler (e.g., ADVAIR DISKUS, FLOVENT DISKUS®; participated in a clinical study of fluticasone propionate/salmeterol, or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- 2. Previous experience with the ELLIPTA inhaler
- Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of FF/VI or GSK573719/GW642444 [umeclidinium/vilanterol], or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- 3. Asthma: Subjects with a current diagnosis of asthma.
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 |
|---|---|---|
| ELLIPTANovel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip) | Device | DISKUS Period 1 and ELLIPTA Period 2 Arm, ELLIPTA Period 1 and DISKUS Period 2 Arm |
| DISKUSMultidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip) | Device | DISKUS Period 1 and ELLIPTA Period 2 Arm, ELLIPTA Period 1 and DISKUS Period 2 Arm |
Primary outcome
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter
Time frame: up to Study Day 26
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.
2 secondary outcomes
Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication
Time frame: up to Study Day 26
Number of Participants With the Indicated Device Preference Based on the Size of the Device
Time frame: up to Study Day 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26516724Yun Kirby S, Zhu CQ, Kerwin EM, Stanford RH, Georges G. A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA(R) Dry Powder Inhaler (DPI) versus DISKUS(R) DPI. COPD. 2016;13(2):167-75. doi: 10.3109/15412555.2015.1057274. Epub 2015 Oct 30.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ELLIPTA and DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in United States.
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 16 inclusion and 20 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter (time frame: up to Study Day 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868009, which also lists 1 linked publication.
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 4 Mar 2014; AzTrials last refreshed its copy on 28 Oct 2026.