Asthma
Conditions
Keywords
ELLIPTA, metered dose inhaler, Dry powder inhaler
Brief summary
The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler use. No active drug will be used in this study in order to prevent any drug-related effects. Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be randomized to receive one of the MDI inhalers, for use during the first period (P) (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in the previous period will receive the ELLIPTA DPI for use during second period (approximately 28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period. ELLIPTA is a registered trademark of the GSK group of companies.
Interventions
DEVICEELLIPTA DPI
It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
DEVICEGSK MDI
It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).
DEVICEAZ MDI
It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Subjects aged 18 years or older, at the time of signing the informed consent * Documented history of moderate persistent asthma * Asthma Control Test (ACT) score \>=20 * Male or Females (who are not pregnant or planning pregnancy during the study or not lactating) * Capable of giving signed informed consent which includes compliance with the requirements and restrictions * 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 * Should not have received maintenance therapy via MDI or ELLIPTA in the past six months (DISKUS (trade name owned by GSK group of companies under license), TWISTHALER (trade name owned by Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co, under license, etc are acceptable). Subject must be on maintenance therapy for 3 months, have not changed dose in the month prior to inclusion and be able to continue using their maintenance therapy throughout the study * Requires Short-acting-beta-agonist (SABA) for symptom control =\<2 days/week. Use of SABA prior to exercise for the prevention of exercise induced bronchoconstriction is exclusionary.
Exclusion criteria
* 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 * Current smokers or subjects with a smoking history of 10 pack-years or more (example, 20 cigarettes/day for 10 years) are not eligible. A subject may not have used tobacco products within the past year (i.e., cigarettes, cigars, or pipe tobacco) * Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases * History of life threatening asthma or has experienced more than 1 exacerbation which required oral/systemic corticosteroids in the 12 months prior to Visit 1 * History of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation * Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, 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 subject at risk through participation, or which would affect the affect the analysis if the disease/condition exacerbated during the study * 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Up to Day 56 | A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately (Sub-study 1: ELLIPTA vs GSK MDI and Sub-study 2: ELLIPTA vs AZ MDI). For each ELLIPTA vs MDI analyses, only par who made no error in any of the inhalers and at least one error on the other inhaler (discordant cases) were included in the analysis. NA indicates that par did not receive the inhaler in that particular sub-study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Up to Day 56 | The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants). |
| Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Up to Day 56 | The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants). |
| Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | Up to Day 56 | The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study. |
| Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error) | Up to Day 56 | The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles). |
Countries
United States
Participant flow
Recruitment details
This is a randomized, multi-center, open-label, cross-over study comparing Placebo ELLIPTA Dry Power Inhaler (DPI) with either Placebo GlaxoSmithKline (GSK) Metered Dose Inhaler (MDI) or Placebo Astra Zeneca (AZ) MDI to assess correct inhaler use. A total of 20 sites in the United States (US) participated in the study.
Pre-assignment details
A total of 329 participants (par) were screened out of which 324 were randomized to sub-study 1 and sub-study 2 in a ratio of 1:1. Each par received at least one-dose of placebo from at least one study inhaler. These par comprised the intent to treat (ITT) population. Par were randomized on the same day as screening.
Participants by arm
| Arm | Count |
|---|---|
| Sub-Study 1 (Seq 3: Ellipta/GSK MDI; Seq 4: GSK MDI/Ellipta) Par were randomized to treatment sequence 3 or 4. In treatment sequence 3, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo GSK MDI at Visit 2 for treatment period 2. In treatment sequence 4, the par were dispensed Placebo GSK MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. GSK MDI contained propellant (1,1,1,2-Tetrafluoroethane). ELLIPTA DPI was taken as one inhalation, once daily and GSK MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period. | 157 |
| Sub-Study 2 (Seq 1: Ellipta/AZ MDI; Seq 2: AZ MDI/Ellipta) Par were randomized to treatment sequence 1 or 2. In treatment sequence 1, the par were dispensed Placebo ELLIPTA DPI at Visit 1 for treatment period 1 and Placebo AZ MDI at Visit 2 for treatment period 2. In treatment sequence 2, the par were dispensed Placebo AZ MDI at Visit 1 for treatment period 1 and Placebo ELLIPTA DPI at Visit 2 for treatment period 2. ELLIPTA was a two strip inhaler with one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. AZ MDI was a placebo inhaler containing liquid aerosol. ELLIPTA DPI was taken as one inhalation, once daily and AZ MDI was taken as two inhalations, twice daily. Par continued taking their asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period. | 153 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1: Treatment Period 1 (28 Days) | Adverse Event | 0 | 0 | 1 | 0 |
| Period 1: Treatment Period 1 (28 Days) | Lost to Follow-up | 0 | 0 | 0 | 2 |
| Period 1: Treatment Period 1 (28 Days) | Protocol Violation | 0 | 0 | 1 | 0 |
| Period 1: Treatment Period 1 (28 Days) | Withdrawal by Subject | 0 | 2 | 0 | 1 |
| Period 2: Treatment Period 2 (28 Days) | Withdrawal by Subject | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Sub-Study 2 (Seq 1: Ellipta/AZ MDI; Seq 2: AZ MDI/Ellipta) | Total | Sub-Study 1 (Seq 3: Ellipta/GSK MDI; Seq 4: GSK MDI/Ellipta) |
|---|---|---|---|
| Age, Continuous | 50.9 Years STANDARD_DEVIATION 15.08 | 51.1 Years STANDARD_DEVIATION 15.46 | 51.4 Years STANDARD_DEVIATION 15.87 |
| Race/Ethnicity, Customized race customized AMERICAN INDIAN OR ALASKA NATIVE | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized race customized ASIAN - CENTRAL/SOUTH ASIAN HERITAGE | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized race customized ASIAN - EAST ASIAN HERITAGE | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized race customized ASIAN - JAPANESE HERITAGE | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized race customized ASIAN - SOUTH EAST ASIAN HERITAGE | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized race customized BLACK OR AFRICAN AMERICAN | 33 Participants | 69 Participants | 36 Participants |
| Race/Ethnicity, Customized race customized MULTIPLE | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized race customized WHITE - ARABIC/NORTH AFRICAN HERITAGE | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized race customized WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 113 Participants | 228 Participants | 115 Participants |
| Sex: Female, Male Female | 108 Participants | 216 Participants | 108 Participants |
| Sex: Female, Male Male | 45 Participants | 94 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 162 | 0 / 162 | 0 / 162 |
| other Total, other adverse events | 12 / 162 | 16 / 162 | 15 / 162 | 17 / 162 |
| serious Total, serious adverse events | 0 / 162 | 0 / 162 | 0 / 162 | 0 / 162 |
Outcome results
Primary
Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase
A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately (Sub-study 1: ELLIPTA vs GSK MDI and Sub-study 2: ELLIPTA vs AZ MDI). For each ELLIPTA vs MDI analyses, only par who made no error in any of the inhalers and at least one error on the other inhaler (discordant cases) were included in the analysis. NA indicates that par did not receive the inhaler in that particular sub-study.
Time frame: Up to Day 56
Population: Modified ITT Population (MITT) comprises of all par in the ITT Population who provided Day 28 inhaler use data for both of their randomized inhalers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | ELLIPTA | 87 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | GSK MDI | 13 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | AZ MDI | NA Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | ELLIPTA | 87 Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | GSK MDI | NA Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | AZ MDI | 13 Percentage of Participants |
p-value: <0.001Mainland-Gart test
p-value: 0.007Mainland-Gart test
Secondary
Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase
The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants).
Time frame: Up to Day 56
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par breathed into the mouthpiece (mp) | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did not take one long steady deep breath | 1 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par didn't exhale when ir was held away from mouth | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par didn't remove ir from mouth and hold breath | 1 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Mp was not placed with lips closed around it | 1 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did not breathe out slowly and gently | 1 Participants |
| Sub-Study 1 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did shake the inhaler (ir) | 3 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did not breathe out slowly and gently | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did shake the inhaler (ir) | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par didn't exhale when ir was held away from mouth | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par breathed into the mouthpiece (mp) | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Mp was not placed with lips closed around it | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par did not take one long steady deep breath | 1 Participants |
| Sub-Study 2 | Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase | Par didn't remove ir from mouth and hold breath | 1 Participants |
Secondary
Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase
The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants).
Time frame: Up to Day 56
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not hold the inhaler with the mp down | 1 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not take finger off the canister | 3 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Mp was not placed with lips closed around it | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not remove inhaler from mouth & closed it | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not check the mp for foreign objects | 14 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par didn't hold breath for 10 s & exhale slowly | 3 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not press top of canister all way down | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not snap the cap back firmly into place | 2 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not breathe out fully | 5 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Inhaler was not kept upright & removed from mouth | NA Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Ability to release actuation was not demonstrated | 4 Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not close the inhaler completely | NA Participants |
| Sub-Study 1 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not shake the inhaler | 5 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not close the inhaler completely | 1 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not shake the inhaler | 5 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not check the mp for foreign objects | 9 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not hold the inhaler with the mp down | NA Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not breathe out fully | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Mp was not placed with lips closed around it | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not press top of canister all way down | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Ability to release actuation was not demonstrated | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not take finger off the canister | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not remove inhaler from mouth & closed it | NA Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par didn't hold breath for 10 s & exhale slowly | 2 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Par did not snap the cap back firmly into place | 0 Participants |
| Sub-Study 2 | Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase | Inhaler was not kept upright & removed from mouth | 2 Participants |
Secondary
Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)
The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles).
Time frame: Up to Day 56
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Study 1 | Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error) | ELLIPTA; n=7, 3 | 1.57 Errors | Standard Deviation 1.134 |
| Sub-Study 1 | Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error) | GSK MDI; n=25, 0 | 2.20 Errors | Standard Deviation 2.062 |
| Sub-Study 2 | Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error) | ELLIPTA; n=7, 3 | 2.00 Errors | Standard Deviation 1 |
| Sub-Study 2 | Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error) | AZ MDI; n=0, 14 | 2.29 Errors | Standard Deviation 1.773 |
Secondary
Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)
The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study.
Time frame: Up to Day 56
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Study 1 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | ELLIPTA | 0.07 Errors | Standard Deviation 0.393 |
| Sub-Study 1 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | GSK MDI | 0.35 Errors | Standard Deviation 1.139 |
| Sub-Study 1 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | AZ MDI | NA Errors | — |
| Sub-Study 2 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | ELLIPTA | 0.04 Errors | Standard Deviation 0.299 |
| Sub-Study 2 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | GSK MDI | NA Errors | — |
| Sub-Study 2 | Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par) | AZ MDI | 0.21 Errors | Standard Deviation 0.838 |
Post Hoc
Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase
A supportive post-hoc analysis on the primary endpoint was performed to address possible concerns due to the exclusion of data from a large number of participants who made no errors or at least one error on either inhaler tested in the primary analysis (only discordant cases involved in the analysis). For each ELLIPTA versus MDI comparison separately (Sub-study 1: Ellipta vs GSK MDI and Sub-study 2: Ellipta vs AZ MDI), the percentage of par having zero errors in inhaler use at Day 28 was analyzed using a Conditional Logistic Regression adjusting for treatment (inhaler) and treatment period. NA indicates that the par did not receive the inhaler in that particular sub-study.
Time frame: Up to Day 56
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use ELLIPTA | 96 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use GSK MDI | 84 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use AZ MDI | NA Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use ELLIPTA | 4 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use GSK MDI | 16 Percentage of Participants |
| Sub-Study 1 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use AZ MDI | NA Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use GSK MDI | NA Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use ELLIPTA | 98 Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use ELLIPTA | 2 Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use GSK MDI | NA Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | At least one Error after 28 Days of Use AZ MDI | 9 Percentage of Participants |
| Sub-Study 2 | Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase | Zero Errors after 28 Days of Use AZ MDI | 91 Percentage of Participants |
p-value: <0.001Conditional Logistic Regression
p-value: 0.011Conditional Logistic Regression