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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo ELLIPTA DPI (QD) in P1 and Placebo AZ MDI (BD) in P2 | Experimental | Eligible subject will receive ELLIPTA DPI taken as one inhalation once daily (QD) for 28 days and Placebo AZ MDI taken as two inhalations twice daily (BD) for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period |
|
| Placebo AZ MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2 | Experimental | Eligible subject will receive AZ MDI taken as two inhalations twice daily for 28 days and Placebo ELLIPTA DPI taken as one inhalation once daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period |
|
| Placebo ELLIPTA DPI (QD) in P1 and Placebo GSK MDI (BD) in P2 | Experimental | Eligible subject will receive ELLIPTA DPI taken as one inhalation once daily for 28 days and Placebo GSK MDI taken as two inhalations twice daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period. |
|
| Placebo GSK MDI (BD) in P1 and Placebo ELLIPTA DPI (QD) in P2 | Experimental | Eligible subject will receive GSK MDI taken as two inhalations twice daily for 28 days and Placebo ELLIPTA DPI taken as one inhalation once daily for next 28 days. Subject will continue to take asthma maintenance treatment and limited rescue albuterol MDI during the entire 56-day study period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELLIPTA DPI | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92648 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30836228 | Background | Kerwin EM, Preece A, Brintziki D, Collison KA, Sharma R. ELLIPTA Dry Powder Versus Metered-Dose Inhalers in an Optimized Clinical Trial Setting. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1843-1849. doi: 10.1016/j.jaip.2019.02.023. Epub 2019 Mar 2. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sub-Study 1 (Seq 3: Ellipta/GSK MDI) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period 1 (28 Days) |
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| GSK MDI | Device | It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol). |
|
| AZ MDI | Device | It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol). |
|
| Up to Day 56 |
| 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). | Up to Day 56 |
| 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. | Up to Day 56 |
| 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). | Up to Day 56 |
| Aventura |
| Florida |
| 33180 |
| United States |
| GSK Investigational Site | Clearwater | Florida | 33756 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | Warrensburg | Missouri | 64093 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28277 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118-2040 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| FG001 | Sub-Study 1 (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. |
| FG002 | Sub-Study 2 (Seq 1: Ellipta/AZ MDI) | 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. |
| FG003 | Sub-Study 2 (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. |
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| NOT COMPLETED |
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| Period 2: Treatment Period 2 (28 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Number | Percentage of Participants | Up to Day 56 |
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| 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). | MITT Population | Posted | Number | Participants | Up to Day 56 |
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| 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). | MITT Population | Posted | Number | Participants | Up to Day 56 |
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| 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. | MITT Population | Posted | Mean | Standard Deviation | Errors | Up to Day 56 |
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| 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). | MITT Population | Posted | Mean | Standard Deviation | Errors | Up to Day 56 |
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| 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. | MITT | Posted | Number | Percentage of Participants | Up to Day 56 |
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On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow up visit (up to 58 days).
On-treatment AEs and SAEs were reported for ITT population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sub-Study 1 - Ellipta (Sequence 3,4) | 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. | 0 | 162 | 0 | 162 | 12 | 162 |
| EG001 | Sub-Study 1 - GSK MDI (Sequence 3,4) | 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. | 0 | 162 | 0 | 162 | 16 | 162 |
| EG002 | Sub-Study 2 - Ellipta (Sequence 1,2) | 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. | 0 | 162 | 0 | 162 | 15 | 162 |
| EG003 | Sub-Study 2 - AZ MDI (Sequence 1,2) | 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. | 0 | 162 | 0 | 162 | 17 | 162 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Iron deficiency | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Sinus operation | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Angular cheilitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Ear disorder | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Cerumen impaction | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Multiple allergies | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
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| Product taste abnormal | Product Issues | MedDRA 19.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
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| ASIAN - CENTRAL/SOUTH ASIAN HERITAGE |
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| ASIAN - EAST ASIAN HERITAGE |
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| ASIAN - JAPANESE HERITAGE |
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| ASIAN - SOUTH EAST ASIAN HERITAGE |
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| BLACK OR AFRICAN AMERICAN |
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| WHITE - ARABIC/NORTH AFRICAN HERITAGE |
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| WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE |
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| MULTIPLE |
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| AZ MDI |
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| 0.007 |
ELLIPTA versus AZ MDI |
| Superiority |
Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects. |
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.
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| Sub-Study 2 |
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. |
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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. |
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| OG001 | Sub-Study 2 | 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. |
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