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The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.
A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the, safety, tolerability, pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of GSK233705 (20 and 50 mcg twice daily), compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily alone, in subjects with chronic obstructive pulmonary disease
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmeterol | Drug | |||
| tiotropium | Drug | |||
| GSK233705 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchodilator effect of salmeterol alone and tiotropium alone compared with placebo and GSK233705 at day 7. Safety and tolerability of GSK233705 plus salmeterol and the 2 active comparators at day 7. |
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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 | Helsinki | 00029 | Finland | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22419863 | Background | Beier J, van Noord J, Deans A, Brooks J, Maden C, Baggen S, Mehta R, Cahn A. Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients. Int J Chron Obstruct Pulmon Dis. 2012;7:153-64. doi: 10.2147/COPD.S26100. Epub 2012 Mar 5. |
| 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 |
|---|---|---|---|
| AC2106956 | Clinical Study Report | 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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| Wiesbaden |
| Hesse |
| 65187 |
| Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Almelo | 7609 PP | Netherlands |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Heerlen | 6419 PC | Netherlands |
| GSK Investigational Site | Veldhoven | 5504 DB | Netherlands |
| GSK Investigational Site | Moscow | 105 229 | Russia |
| GSK Investigational Site | Saint Petersburg | 197 089 | Russia |
| GSK Investigational Site | Upton Road, Slough | Berkshire | SL1 2AD | United Kingdom |
| GSK Investigational Site | Manchester | M23 9QZ | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC2106956 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| 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 |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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