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The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching placebo |
| |
| GSK233705/GW642444 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28. | Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value). | Baseline (Pre-dose, Day 1) and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
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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 | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion. |
| 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 |
|---|---|---|---|
| DB1111581 | Study Protocol | 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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A total of 127 participants were screened out of which 61 participants were enrolled and randomized to receive at least one dose of study medication in the study.
This study was conducted between 13 November 2008 and 12 February 2009, at 12 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Eligible participants received oral inhalation of matching Placebo via dry powder inhaler (DPI) once daily for 28 days. |
| FG001 | GSK233705/GW642444 | Eligible participants received oral inhalation of GSK233705 100 microgram (mcg)/GW642444 25 mcg via DPI once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler. |
|
| On-treatment; from treatment start until one day after treatment stop (Up to Day 29) |
| Wheat Ridge |
| Colorado |
| 80033 |
| United States |
| GSK Investigational Site | Biddeford | Maine | 04005 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Summit | New Jersey | 07091 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37601 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DB1111581 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Eligible participants received oral inhalation of matching Placebo via DPI once daily for 28 days. |
| BG001 | GSK233705/GW642444 | Eligible participants received oral inhalation of GSK233705 100 mcg / GW642444 25 mcg via DPI once daily for 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28. | Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value). | Intent-to-Treat (ITT) Population comprised of all participants who were randomized to study treatment and took at least one dose of study medication. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Beat per minute (bpm) | Baseline (Pre-dose, Day 1) and Day 28 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | ITT Population. | Posted | Number | Participants | On-treatment; from treatment start until one day after treatment stop (Up to Day 29) |
|
On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
Intent to treat population was used to collect the AEs. There were no on-treatment SAEs reported in the study. Only on-treatment SAEs and nSAEs are presented.
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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 | Eligible participants received oral inhalation of matching Placebo via DPI once daily for 28 days. | 0 | 21 | 0 | 21 | 8 | 21 |
| EG001 | GSK233705/GW642444 | Eligible participants received oral inhalation of GSK233705 100 mcg / GW642444 25 mcg via DPI once daily for 28 days. | 0 | 40 | 0 | 40 | 10 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Dry throat | 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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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Muscle injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Venous thrombosis limb | Vascular 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 |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Male |
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| Asian - East Asian Heritage |
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| White - White/Caucasian/European Heritage |
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| Units | Counts |
|---|---|
| Participants |
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