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To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipratropium bromide | Experimental |
| |
| Salbutamol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium bromide | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in pulmonary resistance (Rint) between T0 and T120 | Baseline, 120 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of accessory muscle recruitment on a 4-point scale | Up to 120 minutes after drug administration | |
| Assessment of wheezing on a 4-point scale | Up to 120 minutes after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Salbutamol | Drug |
|
| Assessment of dyspnoea on a 4-point scale | Up to 120 minutes after drug administration |
| Changes in respiratory rate | Up to 120 minutes after drug administration |
| Changes in Oxygen Saturation (ambient air) | Up to 120 minutes after drug administration |
| Changes in measurement of pulmonary resistance | Up to 120 minutes after drug administration |
| Number of patients dropped out because of lack of efficacy | Up to 120 minutes after drug administration |
| Number of patients with adverse events | Up to 17 days after last drug administration |
| Number of patients dropped out because of adverse events | Up to 17 days after last drug administration |
| Number of patients with clinical significant findings in blood pressure | Up to 120 minutes after drug administration |
| Number of patients with clinical significant findings in heart rate | Up to 120 minutes after drug administration |
| Hospital Admission rate | 120 minutes after drug administration |
| Assessment of Patient Status by investigator on a 3-question list | 72 hours after drug admimistration |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D000420 | Albuterol |
| 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 |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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