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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: salbutamol UDV; Drug: ipratropium plus salbutamol UDV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273962

1012.45

Details and patient eligibility

About

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

Full description

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

Enrollment: 500 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind