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Comparison of two asthma treatments by lung function measures.
Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with persistent asthma treated for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/fluticasone propionate and fluticasone propionate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| sRAW measured post-dose at Week 2 and week 4. % symptom-free days over Weeks 1-4. % symptom-free nights over Weeks 1-4. Type and frequency of adverse events. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Manchester | Lancashire | M23 9LT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. | ||
| 17629923 | Derived | Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8(1):52. doi: 10.1186/1465-9921-8-52. |
| 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 |
|---|---|---|---|
| SAM40104 | 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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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40104 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |