Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With HandiHaler DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study Details
Study Description
Brief Summary
This randomized, cross over study aims to find out the benefits of delivering triple therapy using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple therapy using two different types of inhalers (open triple therapy) including DISKUS® with HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in the study. The study will be conducted in 3 visits and will be completed in approximately 56 days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for each period). At Visit 3 (Day 56), subjects will be asked to complete preference questionnaire 1 or 2. There will be no active treatment and subjects will continue to take their own prescribed COPD maintenance and rescue medication during the entire study period. ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies. HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment sequence A Eligible subjects will use ELLIPTA DPI QD for 28 days in Period 1 followed by DISKUS BID with HandiHaler QD use for 28 days in Period 2. These subjects will then be asked to complete preference questionnaire 1 at Visit 3 (Day 56). |
Device: ELLIPTA placebo DPI
ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.
Device: DISKUS placebo DPI
DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.
Device: HandiHaler placebo DPI
HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.
Other: Inhaler preference questionnaires
Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
|
| Experimental: Treatment sequence B Eligible subjects will use ELLIPTA DPI QD for 28 days in Period 1 followed by DISKUS BID with HandiHaler QD use for 28 days in Period 2. These subjects will then be asked to complete preference questionnaire 2 at Visit 3 (Day 56). |
Device: ELLIPTA placebo DPI
ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.
Device: DISKUS placebo DPI
DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.
Device: HandiHaler placebo DPI
HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.
Other: Inhaler preference questionnaires
Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
|
| Experimental: Treatment sequence C Eligible subjects will use DISKUS BID with HandiHaler QD for 28 days in Period 1 followed by ELLIPTA DPI QD use for 28 days in Period 2. These subjects will then be asked to complete preference questionnaire 1 at Visit 3 (Day 56). |
Device: ELLIPTA placebo DPI
ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.
Device: DISKUS placebo DPI
DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.
Device: HandiHaler placebo DPI
HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.
Other: Inhaler preference questionnaires
Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
|
| Experimental: Treatment sequence D Eligible subjects will use DISKUS BID with HandiHaler QD for 28 days in Period 1 followed by ELLIPTA DPI QD use for 28 days in Period 2. These subjects will then be asked to complete preference questionnaire 2 at Visit 3 (Day 56). |
Device: ELLIPTA placebo DPI
ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.
Device: DISKUS placebo DPI
DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.
Device: HandiHaler placebo DPI
HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.
Other: Inhaler preference questionnaires
Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical) [Up to Day 56]
A checklist for correct use of each inhaler was developed in Patient Instruction Leaflets (PIL's). Participants were guided by trained health care provider (HCP) to demonstrate correct use of inhaler. Baseline assessment was conducted when participant initially dispensed the inhaler. Second assessment was conducted after each 28day dosing period. Correct Use Check list was completed by HCP at each visit. Primary hypothetical estimand is the estimate of treatment effect of all participants who stayed on their randomized study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. Participants could attend visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. Participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included
- Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical) [Up to Day 56]
Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included
- Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Supplementary Estimand: Composite) [Up to Day 56]
Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.
- Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase(Supplementary Estimand: Composite) [Up to Day 56]
Supplementary estimand estimated the composite effect of initial randomized treatment. The analysis was performed using stratified exact logistic model. Participants were included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.
Secondary Outcome Measures
- Number of Errors by Type for Each Inhaler After 28 Days of Use in Each Treatment Phase (Primary Estimand: Hypothetical) [Up to Day 56]
The occurrence of each type of error for each inhaler (ELLIPTA, DISKUS or HANDIHALER) were evaluated based on the information collected in Correct Use Checklists. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence & did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups & experienced no intercurrent events were included. The number of error is reported as NA for the type of error which was not applicable to the particular inhaler type
- Number of Errors Per Participant for Each Treatment Group After 28 Days of Use (Primary Estimand: Hypothetical) [Up to Day 56]
Participants were provided with PIL explaining correct use of inhaler. Overall error includes both critical and non-critical errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Change in Errors Per Participant for Each Treatment Group After 28 Days of Use [Day 1 and Day 28 of each treatment group]
Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median number of overall errors made by per participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28 for each treatment group. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Number of Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use (Primary Estimand: Hypothetical) [Up to Day 56]
Participants were provided with the PIL, explaining correct use of the inhaler. Overall error includes both critical and non-critical errors. Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Change in Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use [Day 1 and Day 28 of each treatment group]
Assessment of errors was conducted by health care professionals trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median of overall errors made by each participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Number of Participants With Zero Critical Errors After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical) [Up to Day 56]
A checklist for correct use of each inhaler was developed based on the steps identified in the PIL. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical) [Up to Day 56]
A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.
- Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Supplementary Estimand: Composite) [Up to Day 56]
Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be capable of giving signed informed consent.
-
Subjects must have a diagnosis of COPD with a documented history of COPD for at least 12 months, in accordance with the definition by the American Thoracic Society/European Respiratory Society.
-
Subjects must be 40 years of age inclusive, at the time of signing the informed consent.
-
Male or female subjects will be included. Females must not be pregnant or planning pregnancy during the study or not lactating.
-
Subjects must have a documented post albuterol 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.
-
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 (example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years].
-
All subjects should be currently receiving maintenance treatment for COPD for at least 4 weeks prior to Randomization/Visit 1 and evaluated as unlikely to change COPD treatment within 4 weeks of Visit 1.
-
All subjects should be able to stay on their prescribed maintenance COPD inhaler (s) without change throughout the entire treatment period.
-
Subjects must be able to read, comprehend, and record information in English.
Exclusion Criteria:
-
Subjects must not have a current diagnosis of asthma.
-
Subjects must not have used the ELLIPTA, DISKUS, or HandiHaler inhalers in the 12 months prior to Visit 1.
-
Subjects must not be receiving their current COPD medications with the ELLIPTA, DISKUS, or HandiHaler inhalers.
-
Subjects must not be receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed or regularly scheduled).
-
Subjects must not have experienced more than 1 COPD exacerbation which required hospitalization in the 12 months prior to Visit 1.
-
Subjects must not have a known or suspected history of alcohol or drug abuse within the last 2 years.
-
Subjects must not have a history of hypersensitivity to any component of the study inhalers (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.
-
Subjects with other respiratory disorders, including active tuberculosis, active lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, or pulmonary disease (including but not confined to asthma, bronchiectasis with the need for treatment, cystic fibrosis, and bronchopulmonary dysplasia), interstitial lung diseases or other active pulmonary diseases.
-
Subjects with 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 hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study will be excluded.
-
Subjects with history of psychiatric disease, intellectual impairment, poor motivation or other conditions that will limit the validity of informed consent to participate in the study will be excluded.
-
Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current medications.
-
Subjects who have received an investigational drug and/or medical device/inhaler within 30 days of entry into this study (Screening/Visit 1), or within five drug half-lives of the investigational drug, whichever is longer.
-
Subjects 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Orlando | Florida | United States | 32825 |
| 2 | GSK Investigational Site | Natchitoches | Louisiana | United States | 71457 |
| 3 | GSK Investigational Site | Saint Charles | Missouri | United States | 63301 |
| 4 | GSK Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 5 | GSK Investigational Site | Gastonia | North Carolina | United States | 28054 |
| 6 | GSK Investigational Site | Monroe | North Carolina | United States | 28112 |
| 7 | GSK Investigational Site | Mooresville | North Carolina | United States | 28117 |
| 8 | GSK Investigational Site | Canton | Ohio | United States | 44718 |
| 9 | GSK Investigational Site | Cincinnati | Ohio | United States | 45231 |
| 10 | GSK Investigational Site | Dayton | Ohio | United States | 45419 |
| 11 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73120 |
| 12 | GSK Investigational Site | Medford | Oregon | United States | 97504 |
| 13 | GSK Investigational Site | Anderson | South Carolina | United States | 29621 |
| 14 | GSK Investigational Site | Greenville | South Carolina | United States | 29615 |
| 15 | GSK Investigational Site | Rock Hill | South Carolina | United States | 29732 |
| 16 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 17 | GSK Investigational Site | Richmond | Virginia | United States | 23225 |
| 18 | GSK Investigational Site | Richmond | Virginia | United States | 23229 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
- 206901
Study Results
Participant Flow
| Recruitment Details | This is a randomized, multi-center, open-label study comparing placebo ELLIPTA with placebo DISKUS + HandiHaler to assess correct inhaler use in participants with Chronic Obstructive Pulmonary Disease (COPD). A total of 17 centers across United States participated in the study. |
|---|---|
| Pre-assignment Detail | Out of 240 randomized participants (par), 239 entered the study as 1 par was randomized in error. In order to minimize potential bias the order of placebo devices & order of responses, in preference questionnaire (PQ), was randomized in a crossover design. All par on study received placebo only & participant flow reflects this as the only treatment |
| Arm/Group Title | ELLIPTA/DISKUS+HANDIHALER/Q1 | ELLIPTA/DISKUS+HANDIHALER/Q2 | DISKUS+HANDIHALER/ELLIPTA/Q1 | DISKUS+HANDIHALER/ELLIPTA/Q2 |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) in period 1 and DISKUS DPI + HandiHaler in period 2, followed by preference questionnaire (PQ) version 1. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study | Participants received placebo via ELLIPTA DPI in period 1 and DISKUS DPI + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study | Participants received placebo via DISKUS DPI + HandiHaler in period 1 and ELLIPTA DPI in period 2, followed by PQ1. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study | Participants received placebo via DISKUS DPI + HandiHaler in period 1 and ELLIPTA DPI in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication and rescue medications for the duration of the study |
| Period Title: Period 1 (28 Days) | ||||
| STARTED | 60 | 59 | 60 | 60 |
| COMPLETED | 58 | 57 | 59 | 58 |
| NOT COMPLETED | 2 | 2 | 1 | 2 |
| Period Title: Period 1 (28 Days) | ||||
| STARTED | 58 | 57 | 59 | 58 |
| COMPLETED | 57 | 56 | 57 | 55 |
| NOT COMPLETED | 1 | 1 | 2 | 3 |
Baseline Characteristics
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. |
| Overall Participants | 239 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
65.9
(8.25)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
108
45.2%
|
| Male |
131
54.8%
|
| Race/Ethnicity, Customized (Count of Participants) [Number] | |
| African American/African Heritage |
23
9.6%
|
| White - Arabic/North African Heritage |
3
1.3%
|
| White - White/Caucasian/European Heritage |
213
89.1%
|
Outcome Measures
| Title | Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical) |
|---|---|
| Description | A checklist for correct use of each inhaler was developed in Patient Instruction Leaflets (PIL's). Participants were guided by trained health care provider (HCP) to demonstrate correct use of inhaler. Baseline assessment was conducted when participant initially dispensed the inhaler. Second assessment was conducted after each 28day dosing period. Correct Use Check list was completed by HCP at each visit. Primary hypothetical estimand is the estimate of treatment effect of all participants who stayed on their randomized study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. Participants could attend visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. Participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, and did not have at least one error assessment at Visit 1. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HANDIHALER |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Number [Percentage of participants] |
96
40.2%
|
87
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA, DISKUS + HANDIHALER |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | stratified exact logistic model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 6.88 | |
| Confidence Interval |
(2-Sided) 95% 1.97 to 54.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. | |
| Other Statistical Analysis | There are three intercurrent events identified which could impact upon the estimand of interest: The participant could withdraw from randomised study device sequence and therefore withdraw from the study The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events | |
| Title | Number of Errors by Type for Each Inhaler After 28 Days of Use in Each Treatment Phase (Primary Estimand: Hypothetical) |
|---|---|
| Description | The occurrence of each type of error for each inhaler (ELLIPTA, DISKUS or HANDIHALER) were evaluated based on the information collected in Correct Use Checklists. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence & did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups & experienced no intercurrent events were included. The number of error is reported as NA for the type of error which was not applicable to the particular inhaler type |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS | HandiHaler |
|---|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 | 217 |
| Par exhales while holding inhaler away from mouth |
6
|
9
|
14
|
| Par takes long steady deep breath in through mouth |
2
|
NA
|
NA
|
| Par breathes out slowly and gently |
1
|
NA
|
NA
|
| Par opened cover |
NA
|
1
|
NA
|
| Par slid lever away from mouthpiece |
NA
|
1
|
NA
|
| Par didn't tilt/shake device post dose preparation |
NA
|
2
|
1
|
| Par took a quick deep breath through the Diskus |
NA
|
1
|
NA
|
| Par removed Diskus from mouth,held breath for long |
NA
|
2
|
NA
|
| Par breathed out slowly |
NA
|
1
|
NA
|
| Par closed the cover of the inhaler |
NA
|
2
|
NA
|
| Par did not exhale into the mouthpiece |
NA
|
NA
|
10
|
| Par opened mouthpiece & center chamber is showing |
NA
|
NA
|
1
|
| Par opened only 1 capsule from the blister card |
NA
|
NA
|
5
|
| Par placed capsule in center chamber of inhaler |
NA
|
NA
|
1
|
| Par pressed green piercing button&released button |
NA
|
NA
|
4
|
| Par exhaled fully |
NA
|
NA
|
7
|
| Par closed lips tightly around mouthpiece |
NA
|
NA
|
9
|
| Par didn't block air intake vents with fingers |
NA
|
NA
|
9
|
| Par breathed in deeply |
NA
|
NA
|
10
|
| Par heard or felt the capsule vibrate |
NA
|
NA
|
14
|
| Par held breath for few seconds & removed inhaler |
NA
|
NA
|
10
|
| Par resumed normal breathing |
NA
|
NA
|
9
|
| Par didn't pierce use capsule for 2nd inhalation |
NA
|
NA
|
1
|
| Title | Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical) |
|---|---|
| Description | Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. All participants on study received placebo only and participant flow reflects this as the only treatment. |
| Measure Participants | 217 |
| Atleast 1 error-ELLIPTA&0 errors-DISKUS+HandiHaler |
3
1.3%
|
| Atleast 1error-DISKUS+HandiHaler&0errors-ELLIPTA |
23
9.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Sensitivity Analyses (Primary Estimand: Hypothetical) | |
| Title | Number of Errors Per Participant for Each Treatment Group After 28 Days of Use (Primary Estimand: Hypothetical) |
|---|---|
| Description | Participants were provided with PIL explaining correct use of inhaler. Overall error includes both critical and non-critical errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Median (Full Range) [Errors per participant] |
0.0
|
0.6
|
| Title | Change in Errors Per Participant for Each Treatment Group After 28 Days of Use |
|---|---|
| Description | Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median number of overall errors made by per participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28 for each treatment group. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Day 1 and Day 28 of each treatment group |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Median (Full Range) [Errors per participant] |
0.0
|
0.0
|
| Title | Number of Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use (Primary Estimand: Hypothetical) |
|---|---|
| Description | Participants were provided with the PIL, explaining correct use of the inhaler. Overall error includes both critical and non-critical errors. Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Median (Full Range) [Errors per participant] |
1.0
|
4.4
|
| Title | Change in Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use |
|---|---|
| Description | Assessment of errors was conducted by health care professionals trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median of overall errors made by each participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Day 1 and Day 28 of each treatment group |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Median (Full Range) [Errors per participant] |
0.7
|
2.6
|
| Title | Number of Participants With Zero Critical Errors After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical) |
|---|---|
| Description | A checklist for correct use of each inhaler was developed based on the steps identified in the PIL. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 217 | 217 |
| Count of Participants [Participants] |
215
90%
|
193
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA, DISKUS + HANDIHALER |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | stratified exact logistic model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 8.85 | |
| Confidence Interval |
(2-Sided) 95% 3.45 to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. | |
| Title | Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Supplementary Estimand: Composite) |
|---|---|
| Description | Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. All participants on study received placebo only and participant flow reflects this as the only treatment. |
| Measure Participants | 224 |
| Atleast 1 error-ELLIPTA&0 errors-DISKUS+HandiHaler |
4
1.7%
|
| Atleast 1error-DISKUS+HandiHaler&0errors-ELLIPTA |
27
11.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Sensitivity Analyses (Supplementary Estimand: Composite) | |
| Title | Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical) |
|---|---|
| Description | A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. All participants on study received placebo only and participant flow reflects this as the only treatment. |
| Measure Participants | 217 |
| Atleast 1 critical error with ELLIPTA |
1
0.4%
|
| Atleast 1 critical error with DISKUS+HandiHaler |
23
9.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Sensitivity Analyses (Primary Estimand: Hypothetical) | |
| Title | Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Supplementary Estimand: Composite) |
|---|---|
| Description | Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. All participants on study received placebo only and participant flow reflects this as the only treatment. |
| Measure Participants | 217 |
| Atleast 1 error-ELLIPTA&0 errors-DISKUS+HandiHaler |
3
1.3%
|
| Atleast 1error-DISKUS+HandiHaler&0errors-ELLIPTA |
27
11.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Sensitivity Analyses (Supplementary Composite Estimand) | |
| Title | Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase(Supplementary Estimand: Composite) |
|---|---|
| Description | Supplementary estimand estimated the composite effect of initial randomized treatment. The analysis was performed using stratified exact logistic model. Participants were included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with data available at specified time point were analyzed. |
| Arm/Group Title | ELLIPTA | DISKUS + HandiHaler |
|---|---|---|
| Arm/Group Description | Participants were randomized to use placebo via ELLIPTA in either period 1 or 2. | Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2. |
| Measure Participants | 224 | 224 |
| Number [Percentage of participants] |
95
39.7%
|
85
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ELLIPTA, DISKUS + HANDIHALER |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | stratified exact logistic model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 6.06 | |
| Confidence Interval |
(2-Sided) 95% 2.08 to 24.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. | |
Adverse Events
| Time Frame | Up to Day 56 | |
|---|---|---|
| Adverse Event Reporting Description | Intent-to-Treat Population was used to collect Adverse Events. Since all participants received placebo as treatment, data has been clubbed for all the arms. The non-serious AEs are reported using a frequency threshold of >5% | |
| Arm/Group Title | All Study Participants | |
| Arm/Group Description | Participants received placebo via ELLIPTA dry powder inhaler (DPI) or DISKUS DPI in combination with HandiHaler DPI based on the following treatment sequences: Treatment Sequence A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ 1.); Treatment Sequence B (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2); Treatment Sequence C (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1); or Treatment Sequence D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2). Participants continued to take their own prescribed COPD medication and rescue medications for the entire 56-day study period. | |
All Cause Mortality |
||
| All Study Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/239 (0%) | |
Serious Adverse Events |
||
| All Study Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/239 (4.2%) | |
| Cardiac disorders | ||
| Cardiac failure congestive | 1/239 (0.4%) | 1 |
| General disorders | ||
| Chest pain | 1/239 (0.4%) | 1 |
| Infections and infestations | ||
| Pneumonia | 3/239 (1.3%) | 3 |
| Bronchitis | 1/239 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||
| Hyponatraemia | 1/239 (0.4%) | 1 |
| Nervous system disorders | ||
| Dysarthria | 1/239 (0.4%) | 1 |
| Hemiparesis | 1/239 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease | 5/239 (2.1%) | 5 |
| Acute respiratory failure | 2/239 (0.8%) | 2 |
| Pneumonia aspiration | 1/239 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| All Study Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/239 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| GSKClinicalSupportHD@gsk.com |
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