Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis

Study Overview
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Brief Summary
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Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.

Official Title
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Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis

Conditions
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Asthma

Intervention / Treatment
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* Drug: salbutamol sulfate + ipratropium bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack Patients aged between18 to 40 years Patients able to perform spirometry (PEFR and FEV1) PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value Patients able to sign witnessed informed consent Exclusion Criteria: Patients with very severe or life threatening obstruction, manifested by: Cyanosis of tongue and lips Confusion, drowsiness, coma or exhaustion Silent chest on auscultation or weak respiratory effort PEFR < 25% the predicted normal value Bradycardia (of less 60 beats/min) Patients with a smoking history of more than 10 pack/years Patients with chronic obstructive pulmonary disease (COPD) Patients on treatment for or suspected as having glaucoma Patients with uncontrolled hypertension Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients Female patients known or suspected to be pregnant or nursing Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum Patients with a history of chest surgery Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen Patients who have previously recruited into this study Patients who have been on other investigational drugs within three months prior to study entry Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combivent® aerosol<br> | Drug: salbutamol sulfate + ipratropium bromide<br>* 120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)<br>* Other names: Combivent® aerosol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment |  | 60 and 120 min after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients whose PEFR >= 60% within the first or the second hour |  | 60 and 120 min after start of treatment | 
| Hospitalisation period at the Intensive Care Unit (ICU) |  | up to 3rd hour after treatment | 
| Hospitalisation time at the general ward |  | up to 3rd hour after treatment | 
| Number of relapses and/or new episodes |  | 7 days after finishing treatment |