Official Title: “Combivent UDV vs. Salbutamol UDV (2.5mg) for Treatment of an Acute Exacerbation of Asthma in Children”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: ipratropium plus salbutamol UDV
• Drug: salbutamol UDV

Primary Measures

• The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment

Secondary Measures

• Change in asthma severity scores from baseline to end of treatment; number of patients needing hospitalization; number of rescue medications; oxygen saturation, number of discharged patients revisiting the ER/doctors clinic

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 10 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair B.I. (Phil) Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273962

Study ID Number: 1012.45

ClinicalTrials.gov Identifier: NCT00273962

Health Authority: Philippines: Bureau of Food and Drugs