A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with
 salbutamol alone given every 20 minutes for three doses in asthmatic children with severe
 acute exacerbation
A Comparison of Ipratropium 500mcg and salbutamol 2.5mg (Combivent UDV) and salbutamol UDV
 alone (2.5mg) in a Double-blind, Efficacy and Safety Study in Asthmatic Children with Severe
 Acute Exacerbation

 Study Hypothesis:

 Several studies, including a study conducted in an emergency room setting, demonstrated that
 the addition of ipratropium bromide, an anticholinergic drug, to standard salbutamol therapy
 significantly improves pulmonary function as compared to salbutamol alone.

 Comparison(s):

 Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone
 given every 20 minutes for 3 doses
INCLUSION CRITERIA

 1. All patients must have a known history of asthma and present to the hospital/clinic
 with severe acute exacerbation.

 2. Male or female patients 2 to 10 years of age.

 3. Parents or legal guardians of patients must sign an Informed Consent Form prior to
 participation in the trial.

 EXCLUSION CRITERIA

 1. Patients with known or suspected hypersensitivity to study drugs

 2. Patients with medical condition that would contraindicate the use of beta2-adrenergic
 or anticholinergic medications

 3. Patients with first wheezing episode only

 4. Prior intubation for asthma for more than 24 hours

 5. Patients who used ipratropium within six hours prior to consultation

 6. Patients with concurrent stridor or possible presence of intra-thoracic foreign body

 7. Patients with disease known to have chronic effect on respiratory function ( e.g.,
 cystic fibrosis or cardiac disease)

 8. Patients requiring immediate resuscitation or airway intervention

 9. With psychiatric disease or psychosocial problems

 10. Patients on other investigational drugs or have used any other investigational drugs
 within the past month