Asthma
Conditions
Brief summary
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.
Interventions
DRUGsalbutamol sulfate + ipratropium bromide
120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed