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Trial record 40 of 22305 for:    Placebo AND subjects

Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects

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ClinicalTrials.gov Identifier: NCT02586493
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : February 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Placebo
Other: Questionnaire
Enrollment 278
Recruitment Details Participants who were naive to ELLIPTA (trade name of dry powder inhaler owned by GlaxoSmithKline) inhaler use and had an established diagnosis of Chronic Obstructive Pulmonary Disease (COPD) participated in this study.
Pre-assignment Details  
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
Period Title: Overall Study
Started 278
Completed 266
Not Completed 12
Reason Not Completed
Adverse Event             4
Protocol Violation             6
Lost to Follow-up             1
Withdrawal by Subject             1
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
Overall Number of Baseline Participants 278
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 278 participants
64.8  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants
Female
131
  47.1%
Male
147
  52.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 278 participants
African American/African Heritage 28
American Indian or Alaskan Native 1
White-White/Caucasian/European Heritage 249
1.Primary Outcome
Title 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.
Hide Description 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).
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. Only participants with data available at the analysis time point were analyzed.
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description:
Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
Overall Number of Participants Analyzed 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
93
(90 to 96)
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description:
Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
Overall Number of Participants Analyzed 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
99
(97 to 100)
3.Secondary Outcome
Title The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description:
Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
Overall Number of Participants Analyzed 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
97
(94 to 99)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of Visit 1 until completion of Visit 2 (up to Day 30)
Adverse Event Reporting Description The analysis population used for SAEs and non-serious AEs was Intent-to-Treat population: all participants who were screened and received at least one dose of study treatment (placebo)
 
Arm/Group Title Placebo ELLIPTA Inhaler
Hide Arm/Group Description Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
All-Cause Mortality
Placebo ELLIPTA Inhaler
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ELLIPTA Inhaler
Affected / at Risk (%)
Total   4/278 (1.44%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  4/278 (1.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo ELLIPTA Inhaler
Affected / at Risk (%)
Total   0/278 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02586493     History of Changes
Other Study ID Numbers: 201071
First Submitted: October 22, 2015
First Posted: October 26, 2015
Results First Submitted: October 3, 2016
Results First Posted: February 9, 2017
Last Update Posted: November 9, 2017