Last updated: 11/07/2018 12:42:07
Preference attributes of ELLIPTA dry powder inhaler (DPI) and HANDIHALER DPI in subjects with Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of participants preferring the inhaler based on the number of steps needed to take the COPD medication
Timeframe: Up to 18 days
Secondary outcomes:
Percentage of participants preferring the inhaler based on how easy it was to tell how many doses were left
Timeframe: Up to 18 days
Percentage of participants preferring the inhaler based on the size of the inhaler
Timeframe: Up to 18 days
Interventions:
Drug: Placebo ELLIPTA device
Drug: Placebo capsules for use in HANDIHALER device
Other: Inhaler Preference Questionnaire Version 1
Other: Inhaler Preference Questionnaire Version 2
Enrollment:
214
Observational study model:
Not applicable
Primary completion date:
2016-04-10
Time perspective:
Not applicable
Clinical 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;15(1):46-50.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
June 2016 to October 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- >=40 years of age at Visit 1.
- Diagnosis of COPD with a documented history of COPD for at least 6 months.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- >=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: 1. 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. 2. 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.
Exclusion criteria:
- 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: 1. 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. 2. Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1. 3. 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. 4. Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit 1.
- Other Disease Abnormalities: 1. Subjects with suspected or evidence of oropharyngeal candidiasis. 2. 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. 3. 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 location(s)
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29341
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32825
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Natchitoches, Louisiana, United States, 71457
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-04-10
Actual study completion date
2016-04-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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