Pulmonary Disease, Chronic ObstructivePhase 4NCT02786927
Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Inhaler Preference Questionnaire Version 1 and Inhaler Preference Questionnaire Version 2 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 22 sites in United States.
Trial summary
This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. 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?
- Inhaler Preference Questionnaire Version 1 and Inhaler Preference Questionnaire Version 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 22 sitesUnited States
- Study dates
- 21 Jun 2016to 4 Oct 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
- >=40 years of age at Visit 1.
- Diagnosis of COPD with a documented history of COPD for at least 6 months.
- 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/20) x number of years smoked (for example, 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 therapy with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic), long-acting beta 2-agonist (LABA), or inhaled corticosteroid (ICS)/LABA combination 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) or short acting muscarinic antagonist (SAMA) for rescue use.
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- Has been on current maintenance COPD treatment for at least 4 weeks prior to Screening/Visit 1 and evaluated as unlikely to change COPD treatment within 4 weeks of Visit 1.
- Males or
- Females who are not pregnant or not planning a pregnancy during the study or not lactating.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions defined for this study.
- 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
- 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.
- Recent experience with the ELLIPTA inhaler: Subjects who used any ELLIPTA inhaler within 6 months (180 days) prior to Visit 1.
- Recent experience with the HANDIHALER inhaler: Subjects who used any HANDIHALER inhaler within 6 months (180 days) prior to Visit 1.
- 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.
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- 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.
- Other Disease Abnormalities:
- Subjects with suspected or evidence of oropharyngeal candidiasis.
- 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.
- 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.
- Drug/Food Allergy: A history of hypersensitivity to any components of the study inhaler (for example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
- 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.
- 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
22 sites in 1 country.
22 sites in 1 country
United States22 sites
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Baltimore, Maryland, 21237
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Clearwater, Florida, 33765
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Dayton, Ohio, 45419
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Gaffney, South Carolina, 29341
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Killeen, Texas, 76542
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Natchitoches, Louisiana, 71457
GSK Investigational Site
Orlando, Florida, 32825
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tampa, Florida, 33603
GSK Investigational Site
Union, South Carolina, 29379
About this study
Official title: An Open-label Study to Evaluate the Preference Attributes of the ELLIPTA™ Dry Powder Inhaler (DPI) Compared to the HandiHaler™ DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication.
All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period.
Read more
This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study.
Approximately 211 subjects will be enrolled in the study.
ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo ELLIPTA device, Placebo capsules for use in HANDIHALER device, Inhaler Preference Questionnaire Version 1, Inhaler Preference Questionnaire Version 2
- Keywords
- HANDIHALER, Dry Powder Inhaler, COPD, ELLIPTA, Inhaler preference attributes
- 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.
Placebo ELLIPTA deviceDrug
Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.
Placebo capsules for use in HANDIHALER deviceDrug
Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.
Inhaler Preference Questionnaire Version 1Other
Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
Inhaler Preference Questionnaire Version 2Other
Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
| Study group | Role | What they receive |
|---|---|---|
| ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1 | Experimental | Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. Receives: Drug: Placebo ELLIPTA device; Drug: Placebo capsules for use in HANDIHALER device; Other: Inhaler Preference Questionnaire Version 1 |
| ELLIPTA - HANDIHALER; Questionnaire Version 2 | Experimental | Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire. Receives: Drug: Placebo ELLIPTA device; Drug: Placebo capsules for use in HANDIHALER device; Other: Inhaler Preference Questionnaire Version 2 |
| HANDIHALER - ELLIPTA; Questionnaire Version 1 | Experimental | Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. Receives: Drug: Placebo ELLIPTA device; Drug: Placebo capsules for use in HANDIHALER device; Other: Inhaler Preference Questionnaire Version 1 |
| HANDIHALER - ELLIPTA; Questionnaire Version 2 | Experimental | Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire. Receives: Drug: Placebo ELLIPTA device; Drug: Placebo capsules for use in HANDIHALER device; Other: Inhaler Preference Questionnaire Version 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication
Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.
Measured: Up to 18 days
Secondary outcomes (2)
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left
Preference between ELLIPTA inhaler and Handihaler based on how easy it was to tell how many doses were left was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.
Measured: Up to 18 days
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler
Preference between ELLIPTA inhaler and HandiHaler based on the size of the inhaler was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start21 Jun 2016
- Primary completion4 Oct 2016
- Study completion4 Oct 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 214 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
- NCT02786927
- Sponsor's protocol ID
- 204983
- Status last verified
- Sep 2018
- First submitted
- 26 May 2016
- Last updated
- 15 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Collison KA, Patel P, Preece AF, Stanford RH, Sharma RK, Feldman G. A Randomized Clinical Trial Comparing the ELLIPTA and HandiHaler Dry Powder Inhalers in Patients With COPD: Inhaler-Specific Attributes and Overall Patient Preference. COPD. 2018 Feb;15(1):46-50. doi: 10.1080/15412555.2017.1400000. Epub 2017 Dec 11.
PubMed 29227727
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Preference Attributes of the ELLIPTA™ Dry Powder Inhaler (DPI) Compared to the HandiHaler™ DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02786927
- Acronym / sponsor ID
- 204983
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- HANDIHALER, Dry Powder Inhaler, COPD, ELLIPTA, Inhaler preference attributes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 22 Jun 2017
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 Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication.
All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period.
This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study.
Approximately 211 subjects will be enrolled in the study.
ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1 | Experimental | Drug: Placebo ELLIPTA device, Drug: Placebo capsules for use in HANDIHALER device, Other: Inhaler Preference Questionnaire Version 1Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. |
| ELLIPTA - HANDIHALER; Questionnaire Version 2 | Experimental | Drug: Placebo ELLIPTA device, Drug: Placebo capsules for use in HANDIHALER device, Other: Inhaler Preference Questionnaire Version 2Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire. |
| HANDIHALER - ELLIPTA; Questionnaire Version 1 | Experimental | Drug: Placebo ELLIPTA device, Drug: Placebo capsules for use in HANDIHALER device, Other: Inhaler Preference Questionnaire Version 1Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. |
| HANDIHALER - ELLIPTA; Questionnaire Version 2 | Experimental | Drug: Placebo ELLIPTA device, Drug: Placebo capsules for use in HANDIHALER device, Other: Inhaler Preference Questionnaire Version 2Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- >=40 years of age at Visit 1.
- Diagnosis of COPD with a documented history of COPD for at least 6 months.
- 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/20) x number of years smoked (for example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
- Current COPD Therapy:
Key exclusion criteria (17 listed)
- 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.
- Recent experience with the ELLIPTA inhaler: Subjects who used any ELLIPTA inhaler within 6 months (180 days) prior to Visit 1.
- Recent experience with the HANDIHALER inhaler: Subjects who used any HANDIHALER inhaler within 6 months (180 days) prior to Visit 1.
- Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:
- Other Disease Abnormalities:
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 devicePlacebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate. | Drug | ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1, ELLIPTA - HANDIHALER; Questionnaire Version 2, HANDIHALER - ELLIPTA; Questionnaire Version 1, HANDIHALER - ELLIPTA; Questionnaire Version 2 |
| Placebo capsules for use in HANDIHALER devicePlacebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days. | Drug | ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1, ELLIPTA - HANDIHALER; Questionnaire Version 2, HANDIHALER - ELLIPTA; Questionnaire Version 1, HANDIHALER - ELLIPTA; Questionnaire Version 2 |
| Inhaler Preference Questionnaire Version 1Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses. | Other | ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1, HANDIHALER - ELLIPTA; Questionnaire Version 1 |
| Inhaler Preference Questionnaire Version 2Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses. | Other | ELLIPTA - HANDIHALER; Questionnaire Version 2, HANDIHALER - ELLIPTA; Questionnaire Version 2 |
Primary outcome
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication
Time frame: Up to 18 days
Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.
2 secondary outcomes
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left
Time frame: Up to 18 days
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler
Time frame: Up to 18 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29227727Collison KA, Patel P, Preece AF, Stanford RH, Sharma RK, Feldman G. A Randomized Clinical Trial Comparing the ELLIPTA and HandiHaler Dry Powder Inhalers in Patients With COPD: Inhaler-Specific Attributes and Overall Patient Preference. COPD. 2018 Feb;15(1):46-50. doi: 10.1080/15412555.2017.1400000. Epub 2017 Dec 11.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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
22 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 Inhaler Preference Questionnaire Version 1 and Inhaler Preference Questionnaire Version 2 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 22 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 12 inclusion and 17 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 22 Jun 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 Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication (time frame: Up to 18 days). 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 NCT02786927, 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 15 Oct 2018.