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The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tiotropium inhalation capsules | Experimental |
| |
| Atrovent MDI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium inhalation powder capsules | Drug |
| ||
| Atrovent |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough forced expiratory volume in one second (FEV1) | baseline, day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in forced expiratory volume in one second (FEV1), area under curve from 0 to 3 hours post drug administration | baseline, day 29 | |
| Change from baseline in forced vital capacity (FVC), area under curve from 0 to 3 hours post drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| placebo to Atrovent | Drug |
|
| placebo to tiotropium inhalation capsules | Drug |
|
| baseline, day 29 |
| Change from baseline in total score of patient evaluation questionnaire | baseline, day 29 |
| Number of rescue medications | Up to day 29 |
| Trough forced vital capacity (FVC) response | baseline, day 29 |
| Number of patients with adverse events | up to day 29 |
| Changes in vital signs (blood pressure, pulse rate) | up to day 29 |
| Changes in electrocardiogram | up to day 29 |
| Changes in safety laboratory tests | up to day 29 |
| 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 |
|---|---|
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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