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We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Inhaler |
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| inhaled corticosteroid(ICS)/long acting bronchodilator (LABA) | Active Comparator | ICS/LABA inhaler |
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| ICS | Active Comparator | ICS inhaler |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate | Drug | FF |
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| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29. | Baseline and Day 29 of each treatment period (up to Study Day 197) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29. |
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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 | Berlin | State of Berlin | 14050 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22738148 | Background | Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M. Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012 Jun 27;2(1):11. doi: 10.1186/2045-7022-2-11. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113090 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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This study was a multi-center, randomized, double-blind, placebo controlled, three-period crossover study in mild asthmatic male and female participants. Following the Run-in period, participants were randomized to 1 of 6 treatment sequences of placebo, FF 100 micrograms (µg) once daily (OD), and FF/VI 100/25 µg OD.
Participants were screened within 42 days of the first dose, conducted over 2 days (not consecutive days). During this time, a methacholine challenge and an allergen challenge test were performed. Participants meeting all inclusion criteria and none of the exclusion criteria were randomized to 3 study treatment periods, each lasting 28 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg | Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| FF/Vilanterol (VI; GW642444M) |
| Drug |
FF/VI |
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| Placebo | Drug | Placebo Inhaler |
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| Baseline and Day 29 of each treatment period (up to Study Day 197) |
| Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value | Baseline and Day 29 of each treatment period (up to Study Day 197) |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments. | From the start of study medication until Follow-up/Early Withdrawal (up to 197 days) |
| Wellington |
| 6021 |
| New Zealand |
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
| GSK Investigational Site | Manchester | M23 9QZ | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113090 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg | Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| FG002 | Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo | Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| FG003 | Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg | Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| FG004 | Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg | Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| FG005 | Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo | Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 |
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| Treatment Period 2 |
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| Washout Period 2 |
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| Treatment Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences | All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days. |
| Units | Counts |
|---|---|
| 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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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29. | Intent-to-Treat (ITT) Population: par. randomized to treatment who received >=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Day 29 of each treatment period (up to Study Day 197) |
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| Secondary | Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29. | ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Day 29 of each treatment period (up to Study Day 197) |
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| Secondary | Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value | ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Day 29 of each treatment period (up to Study Day 197) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments. | ITT Population | Posted | Number | participants | From the start of study medication until Follow-up/Early Withdrawal (up to 197 days) |
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Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
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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 | Placebo | Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days. | 0 | 51 | 15 | 51 | ||
| EG001 | FF 100 µg OD | Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. | 0 | 51 | 18 | 51 | ||
| EG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. | 0 | 51 | 11 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA | 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 |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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| Asian - South East Asian Heritage |
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| Mixed Race |
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| Mean Difference (Final Values) |
| 0.145 |
| 2-Sided |
| 95 |
| 0.069 |
| 0.222 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -0.017 | 2-Sided | 95 | -0.091 | 0.057 | No | Superiority or Other |
| OG001 | FF 100 µg OD | Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. |
| OG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. |
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| OG001 | FF 100 µg OD | Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. |
| OG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days. |
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