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The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD). The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of ipratropium bromide | Experimental |
| |
| High dose of Ipratopium bromide | Experimental |
| |
| Atrovent | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of Ipratropium bromide | Drug | One puff, 4 times daily by oral inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1) | up to day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak FEV1 post treatment | up to day 169 | |
| Onset of therapeutic FEV1 response | up to day 169 | |
| Duration of therapeutic FEV1 response |
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Inclusion Criteria:
All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
Male or female patients 40 years of age or older
Patients must have a smoking history of more than ten packs-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform pulmonary function tests and maintain records during the study period, as required in the protocol
Patients must be able to be trained in the proper use of an inhalation aerosol and the Respimat device
All patients must sign an Informed Consent Form prior to participation in the trial i.e., at least 24 hours prior to screening (Visit 1)
Exclusion Criteria:
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| High dose of Ipratropium bromide | Drug | One puff, 4 times daily by oral inhalation |
|
| Atrovent | Drug | Two puffs, 4 times daily by oral inhalation |
|
| Placebo | Drug |
|
| up to day 169 |
| Time to peak FEV1 response | up to day 169 |
| Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response | up to day 169 |
| Average change in forced vital capacity (FVC) from zero to six hours | up to day 169 |
| Peak FVC post treatment | up to day 169 |
| Peak expiratory flow rate (PEFR) measured by the patient at home two times daily | up to day 169 |
| Amount of inhaled rescue medication used during the treatment period | up to day 169 |
| Concomitant medication usage during the treatment period including steroids | up to day 169 |
| Change in patient daily symptom assessments | Baseline, up to day 169 |
| Number of patients with adverse events | Up to day 169 |
| Changes in vital signs (pulse rate, blood pressure) | Baseline, up to day 169 |
| Changes in laboratory tests | Baseline, day 169 |
| Number of patients with significant changes in ECG (electrocardiogram) | Baseline, day 169 |
| Changes in physical examination | Baseline, day 169 |
| 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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