AsthmaNCT02135718
ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma
An observational study of Asthma, run by GlaxoSmithKline at 15 sites in United States.
Trial summary
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- ELLIPTA inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2014to Jul 2014
- Phase
- Observational
- 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
Study population: Diagnosed and treated asthma patients aged 18 years or older
Who may be able to join
- 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.
- Age: >=18 years of age at Visit 1
- Gender: Male or non-pregnant female subjects. Female subjects must not be pregnant at the time of Visit 1 based on the investigator's evaluation during medical history and physician examination.
- Asthma Diagnosis: Asthma as defined by the National Institutes of Health
- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 milliliter (mL) reversibility of forced expiratory volume in one second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) within 24 months of Visit 1.
- Ability to use Inhalers: Subjects must demonstrate the ability to correctly use the ELLIPTA and MDI inhalers.
- Current asthma therapy: Subjects must be using one of the following three stable asthma therapies for at least 3 months prior to screening: a. Currently using a DPI as an inhaled asthma controller therapy; OR b. Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months); OR c. Currently using no inhaled asthma controller therapy (this includes patients using a leukotriene modifiers (LTM) and/or short-acting beta2-agonists (SABA) as rescue only). All subjects will be allowed the concomitant use of their currently prescribed asthma treatment(s) throughout the study, including rescue albuterol MDI (SABA) as needed.
Who cannot join
- Pregnant: Women who are pregnant or lactating.
- MDI daily controller therapy: Subjects using Fluticatsone propionate (fluticasone HFA) MDI during the last 3 months.
- ELLIPTA USE: Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of fluticasone furoate (FF) or FF/vilanterol (VI) or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- Asthma Control: Subjects who in the investigator's judgment have poorly controlled or have unstable asthma.
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current primary diagnosis of COPD.
- History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
Show all 14Show fewer
- Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 1 month of Visit 1. A subject must not have had any hospitalization for asthma within 3 months prior to Visit 1.
- Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary 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.
- Oropharyngeal Examination: A subject will not be eligible for the study if he/she has clinical visual evidence of oral candidiasis at Visit 1.
- Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1.
- Drug Allergy: Known or suspected sensitivity to the constituents of the placebo dry powder inhaler or MDI (i.e. lactose or magnesium stearate).
- Milk Protein Allergy: History of severe milk protein allergy.
- Tobacco Use. Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years)
- Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Vista, California, 92083
About this study
Official title: A Preference Study of Inhaler Attributes Between Two Inhalers; ELLIPTA and MDI, in Adult Subjects With Asthma
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria will be stratified according to their current inhaler use (stable for the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1 presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects answered questions which assessed their preference of inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
- Conditions
- Asthma
- Being tested
- ELLIPTA inhaler, Placebo Inhalation Aerosol (MDI)
- Keywords
- ELLIPTA, Asthma, Inhaler preference, Fluticasone furoate, ELLIPTA inhaler, Dry Powder Inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELLIPTA inhalerDevice
ELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip)
Placebo Inhalation Aerosol (MDI)Device
Placebo inhaler MDI will be supplied containing aerosol propellant
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the MDI inhaler twice daily for 5 to 9 days during the second period. Receives: Device: ELLIPTA inhaler; Device: Placebo Inhalation Aerosol (MDI) | |
| Group 2 | Subjects will use the MDI 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 inhaler; Device: Placebo Inhalation Aerosol (MDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the indicated inhaler preference based on the number of steps needed to use the inhaler
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the number of steps needed to use the inhaler was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.
Measured: Up to Day 18
Secondary outcomes (2)
Number of participants with the indicated inhaler preference based on how easy it is to tell how many doses you have left
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on how easy it is to tell how many doses you have left was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.
Measured: Up to Day 18
Number of participants with the indicated inhaler preference based on the comfort of the mouthpiece
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the comfort of the mouthpiece was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.
Measured: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 288 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
- NCT02135718
- Sponsor's protocol ID
- 201344
- Status last verified
- Jun 2016
- First submitted
- 8 May 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preference Study of Inhaler Attributes Between Two Inhalers; ELLIPTA and MDI, in Adult Subjects With Asthma
- ClinicalTrials.gov ID
- NCT02135718
- Acronym / sponsor ID
- 201344
- Conditions
- Asthma
- Keywords
- ELLIPTA, Asthma, Inhaler preference, Fluticasone furoate, ELLIPTA inhaler, Dry Powder Inhaler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 May 2014 (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.
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria will be stratified according to their current inhaler use (stable for the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1 presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects answered questions which assessed their preference of inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: ELLIPTA inhaler, Device: Placebo Inhalation Aerosol (MDI)Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the MDI inhaler twice daily for 5 to 9 days during the second period. |
| Group 2 | – | Device: ELLIPTA inhaler, Device: Placebo Inhalation Aerosol (MDI)Subjects will use the MDI 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed and treated asthma patients aged 18 years or older
Key inclusion criteria (7 listed)
- 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.
- Age: >=18 years of age at Visit 1
- Gender: Male or non-pregnant female subjects. Female subjects must not be pregnant at the time of Visit 1 based on the investigator's evaluation during medical history and physician examination.
- Asthma Diagnosis: Asthma as defined by the National Institutes of Health
- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 milliliter (mL) reversibility of forced expiratory volume in one second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) within 24 months of Visit 1.
Key exclusion criteria (14 listed)
- Pregnant: Women who are pregnant or lactating.
- MDI daily controller therapy: Subjects using Fluticatsone propionate (fluticasone HFA) MDI during the last 3 months.
- ELLIPTA USE: Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of fluticasone furoate (FF) or FF/vilanterol (VI) or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- Asthma Control: Subjects who in the investigator's judgment have poorly controlled or have unstable asthma.
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current primary diagnosis of COPD.
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 |
|---|---|---|
| ELLIPTA inhalerELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip) | Device | Group 1, Group 2 |
| Placebo Inhalation Aerosol (MDI)Placebo inhaler MDI will be supplied containing aerosol propellant | Device | Group 1, Group 2 |
Primary outcome
Number of participants with the indicated inhaler preference based on the number of steps needed to use the inhaler
Time frame: Up to Day 18
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the number of steps needed to use the inhaler was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.
2 secondary outcomes
Number of participants with the indicated inhaler preference based on how easy it is to tell how many doses you have left
Time frame: Up to Day 18
Number of participants with the indicated inhaler preference based on the comfort of the mouthpiece
Time frame: Up to Day 18
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 8 Jun 2016.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 15 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 7 inclusion and 14 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
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?
Number of participants with the indicated inhaler preference based on the number of steps needed to use the inhaler (time frame: Up to Day 18). 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 8 Jun 2016.