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Different medications are often used in combination for the condition COPD (chronic obstructive pulmonary disease). Some medicines act by opening the airways (bronchodilators) and some act as anti-inflammatories (steroids). More recently an approach of using a combination inhaler (containing a steroid and a long-acting bronchodilator) at the same time as a long acting bronchodilator of a different group of medicines (anti-cholinergics inhalers) has been used. This approach is sometimes called 'triple therapy'. Studies which have looked at these combinations usually use only standard blowing tests (spirometry) to test these medicines and focus on the effects of the medicines at their highest (peak) levels. It is some ways more relevant to study these medicines towards to end of the dose period (trough)- just before the next dose. This is when there is less medicine in the system, and differences in drug effects are more obvious. There are also more detailed breathing tests than spirometry which get a more detailed picture of the way the lungs respond to bronchodilator medicines. The investigators have studied 'triple therapy' in COPD, by measuring the effects at the end of the dosing interval (trough) using a range of detailed respiratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple therapy | Active Comparator | Symbicort and tiotropium |
|
| Combination therapy | Placebo Comparator | Symbicort and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol and tiotropium | Drug | Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination | 2 weeks | |
| Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Research Group, Ninewells Hospital and Medical School | Dundee | Tayside | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20418370 | Result | Williamson PA, Short PM, Clearie KL, Vaidyanathan S, Fardon TC, Howaniec LJ, Lipworth BJ. Paradoxical trough effects of triple therapy with budesonide/formoterol and tiotropium bromide on pulmonary function outcomes in COPD. Chest. 2010 Sep;138(3):595-604. doi: 10.1378/chest.10-0247. Epub 2010 Apr 23. |
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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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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide/formoterol and placebo | Drug | Symbicort 200/6 2puff bid and placebo |
|
| 4 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| 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 |