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The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.
At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.
Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADOAIR250 | Experimental | ADOAIR 250mcg inhalations, twice daily, from week0 - 12 |
|
| Placebo | Placebo Comparator | Placebo inhalation, twice daily, from week0 -12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADOAIR250 | Drug | 250 mcg inhalation, twice daily, from week0 -12. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neutrophil Count in Induced Sputum at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
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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 | Osaka | 530-0001 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25945045 | Derived | Asai K, Kobayashi A, Makihara Y, Johnson M. Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Apr 17;10:803-11. doi: 10.2147/COPD.S79842. eCollection 2015. |
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At Visit 1, participants meeting the inclusion criteria and not meeting any of the exclusion criteria entered a 4-week Run-in Period. At the end of the Run-in Period (Visit 2), eligible participants were randomized to a 12-week Treatment Period.
Japanese participants with Chronic Obstructive Pulmonary Disease (COPD) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
| FG001 | ADOAIR 250 | Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
| BG001 | ADOAIR 250 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data are reported for members of the Per Protocol Population, comprised of all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. |
| 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 | Change From Baseline in Neutrophil Count in Induced Sputum at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value). | Per Protocol Population: all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. Only those participants available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | ratio (%) | Baseline and Week 12 |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the start of administration of the study drug until the end of follow-up (approximately up to Week 13).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
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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 self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo |
| Drug |
Placebo inhalation, twice daily, from week0 -12. |
|
| Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12 | INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, "no result"/"no data" was entered into the case report forms, and no statistical analysis or data summarization was performed. | Baseline and Week 12 |
| Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
| Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12 | Data cannot be reported because hsCRP was under the lower limit of detection in all samples. | Baseline and Week 12 |
| Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
| Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12 | Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
| Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12 | Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
| Change From Baseline in Fibrinogen Levels in Serum at Week 12 | Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure. | Baseline and Week 12 |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12 | FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, "I never cough"; 5, "I cough all the time." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, "I have no phlegm (mucus) in my chest at all"; 5, "My chest is completely full of phlegm (mucus)." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, "My chest does not feel tight at all"; 5, "My chest feels very tight." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, "When I walk up a hill or one flight of stairs I am not breathless"; 5, "When I walk up a hill or one flight of stairs I am very breathless." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, "I am not limited doing any activities at home"; 5, "I am very limited doing activities at home." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, "I am confident leaving my home despite my lung condition"; 5, "I am not at all confident leaving my home because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, "I sleep soundly"; 5, "I don't sleep soundly because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, "I have lots of energy"; 5, "I have no energy at all." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Baseline and Week 12 |
| Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period | The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized. | From Baseline up to Week 12 |
| Osaka |
| 545-8586 |
| Japan |
| GSK Investigational Site | Osaka | 559-0011 | Japan |
Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline data are reported for members of the Per Protocol Population, comprised of all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline data are reported for members of the Per Protocol Population, comprised of all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. | Number | participants |
|
Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
| OG001 | ADOAIR 250 | Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. |
|
|
|
| Secondary | Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population. Only those participants available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Cells per millimeters cubed (cells/mm^3) | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12 | INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, "no result"/"no data" was entered into the case report forms, and no statistical analysis or data summarization was performed. | Posted | Baseline and Week 12 |
|
|
| Secondary | Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population. Only those participants available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Picograms per milliliter (pg/mL) | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12 | Data cannot be reported because hsCRP was under the lower limit of detection in all samples. | Posted | Baseline and Week 12 |
|
|
| Secondary | Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12 | Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population. Only those participants available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | ng/mL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12 | Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population | Posted | Median | Inter-Quartile Range | pg/mL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12 | Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population | Posted | Median | Inter-Quartile Range | ng/mL | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Fibrinogen Levels in Serum at Week 12 | Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure. | Posted | Baseline and Week 12 |
|
|
| Secondary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12 | FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value. | Per Protocol Population | Posted | Median | Inter-Quartile Range | Liters (L) | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, "I never cough"; 5, "I cough all the time." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, "I have no phlegm (mucus) in my chest at all"; 5, "My chest is completely full of phlegm (mucus)." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, "My chest does not feel tight at all"; 5, "My chest feels very tight." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, "When I walk up a hill or one flight of stairs I am not breathless"; 5, "When I walk up a hill or one flight of stairs I am very breathless." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, "I am not limited doing any activities at home"; 5, "I am very limited doing activities at home." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, "I am confident leaving my home despite my lung condition"; 5, "I am not at all confident leaving my home because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, "I sleep soundly"; 5, "I don't sleep soundly because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, "I have lots of energy"; 5, "I have no energy at all." Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12 | Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score. | Per Protocol Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period | The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized. | Per Protocol Population | Posted | Number | Participants | From Baseline up to Week 12 |
|
|
|
| 2 |
| 28 |
| 12 |
| 28 |
| EG001 | ADOAIR 250 | Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study. | 1 | 28 | 14 | 28 |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| CC-16 |
|
| 2 moderate exacerbations |
|
| >=3 moderate exacerbations |
|
| 0 severe exacerbations |
|
| 1 severe exacerbation |
|
| 2 severe exacerbations |
|
| >=3 severe exacerbations |
|
| 0 overall exacerbations |
|
| 1 overall exacerbation |
|
| 2 overall exacerbations |
|
| >=3 overall exacerbations |
|