A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Albuterol; Ipratropium

Criteria

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