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To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | |||
| Salmeterol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period. | up to day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum decline in PaO2 from baseline | up to day 90 | |
| Maximum increase in alveolar-arterial oxygen gradient from baseline | up to day 90 | |
| Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter |
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hines Veterans Administration Hospital | Hines | Illinois | United States | |||
| Hunter Holmes McGuire Medical Center |
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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 |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| up to day 90 |
| Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter | up to day 90 |
| Rescue medication use | up to day 90 |
| COPD symptom score | up to day 90 |
| Occurrence of adverse events | up to day 90 |
| Pulse rate and sitting blood pressure in conjunction with spirometry | up to day 90 |
| Richmond |
| Virginia |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |