DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)

NCT01868009 | Completed Phase 3 Results

• 1 other identifier: 116669
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 17

Brief Summary

Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers. The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity. The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

fluticasone furoate; COPD; ELLIPTA; fluticasone propionate; DISKUS; Novel Dry Powder Inhaler (NDPI); device preference; salmeterol; vilanterol

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter

  The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.

  up to Study Day 26

Secondary Outcomes (2)

• Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication

  up to Study Day 26

• Number of Participants With the Indicated Device Preference Based on the Size of the Device

  up to Study Day 26

Study Arms (2)

ELLIPTA Period 1 and DISKUS Period 2 Arm

EXPERIMENTAL

Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period.

Device: ELLIPTA; Device: DISKUS

DISKUS Period 1 and ELLIPTA Period 2 Arm

EXPERIMENTAL

Subjects will use the DISKUS 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.

Device: ELLIPTA; Device: DISKUS

Interventions

ELLIPTA DEVICE

Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip)

DISKUS Period 1 and ELLIPTA Period 2 Arm; ELLIPTA Period 1 and DISKUS Period 2 Arm

DISKUS DEVICE

Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip)

DISKUS Period 1 and ELLIPTA Period 2 Arm; ELLIPTA Period 1 and DISKUS Period 2 Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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: \>=40 years of age at Visit 1
• \. Gender: Male or female subjects
• \. COPD diagnosis subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
• \. Severity of disease:
• Subject with a measured post-albuterol Forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) ratio of \<=0.70 at Visit 1
• Subjects with a measured post-albuterol FEV1 \<=70% of predicted normal values calculated using Third National Health and Nutrition Examination Survey reference equations at Visit 1.
• Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400 micrograms) of albuterol via a metered dose inhaler (MDI) with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated by the investigator site.
• Documented spirometry measurements that meet this criterion in the last 12 months preceding Visit 1 is acceptable.
• \. Tobacco use: current or former smokers
• Smokers are defined as those who smoke 10 pack-years of cigarette.
• Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

You may not qualify if:

• \. Previous experience with the DISKUS inhaler
• Subjects who used any DISKUS inhaler (e.g., ADVAIR DISKUS, FLOVENT DISKUS®; participated in a clinical study of fluticasone propionate/salmeterol, or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
• \. Previous experience with the ELLIPTA inhaler
• Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of FF/VI or GSK573719/GW642444 \[umeclidinium/vilanterol\], or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
• \. 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.
• \. 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.
• 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 diseases/abnormalities: Subjects with current evidence of uncontrolled or clinically significant 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.
• Subjects with suspected or evidence of oropharyngeal candidiasis will be excluded from the study.
• Note: subjects who develop oropharyngeal candidiasis during the study will be treated at the discretion of the investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Clearwater, Florida, 33765-2616, United States

Location

GSK Investigational Site

Leesburg, Florida, 34748, United States

Location

GSK Investigational Site

Orlando, Florida, 32825, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Easley, South Carolina, 29640, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Seneca, South Carolina, 29678, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Richmond, Virginia, 23225, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• Yun Kirby S, Zhu CQ, Kerwin EM, Stanford RH, Georges G. A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA(R) Dry Powder Inhaler (DPI) versus DISKUS(R) DPI. COPD. 2016;13(2):167-75. doi: 10.3109/15412555.2015.1057274. Epub 2015 Oct 30.

  PMID: 26516724 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 4, 2014
• Results First Posted: March 4, 2014

Record last verified: 2013-12

Locations

US (17)