A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: ipratropium plus salbutamol UDV (Drug); salbutamol UDV (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. (Phil) Inc.
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
Clinical Details
Official title: Combivent UDV vs. Salbutamol UDV (2.5mg) for Treatment of an Acute Exacerbation of Asthma in Children
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment
Secondary outcome: 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
Detailed 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
Eligibility
Minimum age: 2 Years.
Maximum age: 10 Years.
Gender(s): Both.
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
Locations and Contacts
Philipines Heart Center, Quezon City, Philippines
San Juan de Dios Hospital, Pasay, Philippines
Philippine Children's Medical Center, Quezon 1104, Philippines
Philippine General Hospital, Manila, Philippines
Rizal Provincial Hospital, Pasig, Philippines
Jose Reyes Memorial Medical Center, Manila, Philippines
Amang Rodriguez Hospital, Marikina, Philippines
Quezon City General Hospital, Quezon, Philippines
East Ave Medical Center, Quezon City, Philippines
Quirino Memorial Medical Center, Quezon City, Philippines
Additional Information
Starting date: May 2002
Ending date: November 2003
Last updated: March 6, 2008
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