Pulmonary Disease, Chronic ObstructivePhase 4NCT02586493
Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects
A Phase 4 study testing Questionnaire in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 16 sites in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. 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?
- Questionnaire
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Oct 2015to 15 Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >=40 years of age at Visit 1
- Diagnosis of COPD with a documented history of COPD for at least one year, in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1.
- Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history (Number of pack years = [number of cigarettes per day divided by 20] x number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]).
- Current COPD Therapy: Currently receiving maintenance (with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic 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.
- Informed Consent: Capable of giving signed and dated written informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the 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
- Asthma: Subjects with a current primary diagnosis of asthma.
- COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans to change COPD treatment within 4 weeks of Visit 1.
- COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics within four weeks of Visit 1. A subject must not have had any hospitalization for COPD within three months prior to Visit 1; Subjects with uncontrolled COPD, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use".
- Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening/Visit 1.
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- Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed for greater than 12 hours per day) or nocturnal oxygen.
- Other Disease Abnormalities: Historical or current evidence of clinically significant or rapidly progressing or unstable 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 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.
- Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications.
- 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 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
16 sites in 1 country.
16 sites in 1 country
United States16 sites
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Clearwater, Florida, 33765
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Orlando, Florida, 32825
GSK Investigational Site
Ormond Beach, Florida, 32174
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
Seneca, South Carolina, 29678
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Union, South Carolina, 29379
About this study
Official title: An Open-label Study of the Correct Use and Ease of Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and 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 COPD and receiving COPD 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
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo, Questionnaire
- Keywords
- Placebo, ELLIPTA inhaler, Correct use, COPD, Ease of use
- 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.
PlaceboDrug
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; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate 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. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).
Measured: Day 30
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 30
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 1 and 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 30
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 completion1 Mar 2016
- Study completion15 Mar 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 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 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
- NCT02586493
- Sponsor's protocol ID
- 201071
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2015
- Last updated
- 9 Nov 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 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Correct Use and Ease of Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02586493
- Acronym / sponsor ID
- 201071
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Placebo, ELLIPTA inhaler, Correct use, COPD, Ease of use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 15 Mar 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.
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and 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 COPD and receiving COPD 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, 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
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: >=40 years of age at Visit 1
- Diagnosis of COPD with a documented history of COPD for at least one year, in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1.
- Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history (Number of pack years = [number of cigarettes per day divided by 20] x number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]).
- Current COPD Therapy: Currently receiving maintenance (with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) for rescue use.
Key exclusion criteria (13 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply
- Asthma: Subjects with a current primary diagnosis of asthma.
- COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans to change COPD treatment within 4 weeks of Visit 1.
- COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics within four weeks of Visit 1. A subject must not have had any hospitalization for COPD within three months prior to Visit 1; Subjects with uncontrolled COPD, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use".
- Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
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 |
|---|---|---|
| PlaceboSubjects 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
Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.
Time frame: Day 30
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. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).
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 30
The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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
16 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 Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 16 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 13 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study. (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 9 Nov 2017.