AsthmaPhase 4NCT02586506
Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
A Phase 4 study testing Questionnaire in people with Asthma, run by GlaxoSmithKline at 15 sites in United States.
Trial summary
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Oct 2015to 4 Feb 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Age: >=18 years of age at Screening at Visit 1
- Diagnosis: Asthma as defined by the National Institutes of Health
- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent nebulized treatment with albuterol solution) within 24 months of Visit 1
- Current asthma Therapy: Currently receiving maintenance (with one or more of the following therapies: e.g. inhaled corticosteroid alone or in combination with long-acting bronchodilators, such as long-acting beta 2-agonist [LABA]) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of asthma. Subjects must be able to continue using their currently prescribed asthma maintenance inhaler therapy throughout the study and as needed short acting betaadrenergic agonist (SABA) for rescue use.
- Ability to Use Inhalers: Subject must be able to demonstrate correct use of ELLIPTA inhaler within three attempts at Visit 1.
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- Males
- Females who are not pregnant or not planning a pregnancy during the study or not lactating.
- Capable of giving signed and dated written informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
- 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.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD.
- Asthma medications:
- Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily asthma therapy (as needed [prn] or regularly scheduled).
- Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans to change asthma treatment within 4 weeks of Visit 1.
- Asthma/Exacerbations/Hospitalization:
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- Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not have any hospitalisation or emergency department visit due to asthma within 3 months of Visit 1.
- Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use".
- History of life-threatening asthma, defined an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, 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), interstitial lung diseases or other active pulmonary diseases.
- Other Disease Abnormalities:
- Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. 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 affect the analysis if the disease/condition exacerbated during the study.
- Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- Oropharyngeal Examination: Subjects with clinical visual evidence of oral candidiasis at Visit 1 are not eligible.
- Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current asthma medications.
- Tobacco Use: Current smokers or subjects with a smoking history of 10 pack-years or more (e.g., 20 cigarettes/day for 10 years) are not eligible. A subject may not have used tobacco products within the past year (i.e., cigarettes, cigars, or pipe tobacco).
- Alcohol and Drug Abuse A known or suspected history of alcohol or drug abuse within the last 2 years.
- A history of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
- Prior or Ongoing use of the ELLIPTA inhaler (including both investigational and commercially available product).
- Investigational Product: Subjects who have received an investigational drug and/or medical device/inhaler within 30 days of entry into this study (Screening/Visit 1), or within five drug half-lives of the investigational drug, whichever is longer
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Charlotte, North Carolina, 28277
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Waco, Texas, 76712
About this study
Official title: An Open-label Study of the Ease of Use and Correct Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Asthma
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.
ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
- Conditions
- Asthma
- Being tested
- Placebo ELLIPTA inhaler, Questionnaire
- Keywords
- correct use of inhaler, dose left, ease of use, ELLIPTA, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ELLIPTA inhalerDrug
The ELLIPTA Dry Powder Inhaler (DPI) is a molded plastic two-sided inhaler that can hold two individual blister strips. Each strip will contain either lactose or a blend of lactose and magnesium stearate. Subjects will receive 1 inhalation once-daily until visit 2.
QuestionnaireOther
ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Placebo ELLIPTA inhaler | Experimental | Subjects will be provided the ELLIPTA inhaler, which is a molded plastic two-sided inhaler that holds two individual blister strips containing either lactose or a blend of lactose and magnesium stearate. Subjects will continue to use regular COPD medications throughout the study as per protocol. Receives: Drug: Placebo ELLIPTA inhaler; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.
Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.
Measured: Day 28
Secondary outcomes (2)
The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study
Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.
Measured: Day 28
The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study
Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion4 Feb 2016
- Study completion4 Feb 2016
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 259 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
- NCT02586506
- Sponsor's protocol ID
- 201594
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2015
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Ease of Use and Correct Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT02586506
- Acronym / sponsor ID
- 201594
- Conditions
- Asthma
- Keywords
- correct use of inhaler, dose left, ease of use, ELLIPTA, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 4 Feb 2016 (actual)
- Study completion
- 4 Feb 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 9 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.
ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo ELLIPTA inhaler | Experimental | Drug: Placebo ELLIPTA inhaler, Other: QuestionnaireSubjects will be provided the ELLIPTA inhaler, which is a molded plastic two-sided inhaler that holds two individual blister strips containing either lactose or a blend of lactose and magnesium stearate. Subjects will continue to use regular COPD medications throughout the study as per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Age: >=18 years of age at Screening at Visit 1
- Diagnosis: Asthma as defined by the National Institutes of Health
- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent nebulized treatment with albuterol solution) within 24 months of Visit 1
- Current asthma Therapy: Currently receiving maintenance (with one or more of the following therapies: e.g. inhaled corticosteroid alone or in combination with long-acting bronchodilators, such as long-acting beta 2-agonist [LABA]) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of asthma. Subjects must be able to continue using their currently prescribed asthma maintenance inhaler therapy throughout the study and as needed short acting betaadrenergic agonist (SABA) for rescue use.
Key exclusion criteria (20 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD.
- Asthma medications:
- Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily asthma therapy (as needed [prn] or regularly scheduled).
- Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans to change asthma treatment within 4 weeks of Visit 1.
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 |
|---|---|---|
| Placebo ELLIPTA inhalerThe ELLIPTA Dry Powder Inhaler (DPI) is a molded plastic two-sided inhaler that can hold two individual blister strips. Each strip will contain either lactose or a blend of lactose and magnesium stearate. Subjects will receive 1 inhalation once-daily until visit 2. | Drug | Placebo ELLIPTA inhaler |
| QuestionnaireELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2. | Other | Placebo ELLIPTA inhaler |
Primary outcome
The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.
Time frame: Day 28
Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.
2 secondary outcomes
The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study
Time frame: Day 28
The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 4 study testing Questionnaire in people with 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 11 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 11 Oct 2017. 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.
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?
Yes. Results are posted in the registry (first posted 9 Feb 2017). 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?
The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study. (time frame: Day 28). 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 11 Oct 2017.