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The primary objective of this study was to investigate patients acceptability / preference of BerodualĀ® RespimatĀ® inhaler as compared to the conventional BerodualĀ® Metered Aerosol (MA) inhaler. Ease of handling and assembling the RespimatĀ® inhaler at home under real life conditions was also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BerodualĀ® RespimatĀ® - BerodualĀ® MA HFA | Experimental | randomized sequence
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BerodualĀ® RespimatĀ® | Drug |
| ||
| BerodualĀ® MA HFA |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's assessment of inhaler preference | patient preference questionnaire | Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Rating of inhaler satisfaction | patient satisfaction questionnaire | Day 49 and 98 |
| Rating of willingness to continue using inhaler | patient preference questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Day 98 |
| Post-dose PEFRpm (Peak expiratory flow rate) | 30 minutes post-dose up to day 98 |
| Retention of inhaler technique | proficiency questionnaire | day 49 and 98 (after 7 weeks of treatment) |
| Use of rescue medication | up to day 98 |
| Daytime and night-time symptom scores | up to day 98 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| 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 |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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