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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
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

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: A Comparison of Combivent® UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg) in a Double-Blind Efficacy and Safety Study in Asthmatic Children With Severe Acute Exacerbation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Jose Reyes Memorial Medical Center, Manila, Philippines

Philippine General Hospital, Manila, Philippines

Amang Rodriguez Hospital, Marikina, Philippines

San Juan de Dios Hospital, Pasay, Philippines

Rizal Provincial Hospital, Pasig, Philippines

East Ave Medical Center, Quezon City, Philippines

Philipines Heart Center, Quezon City, Philippines

Quirino Memorial Medical Center, Quezon City, Philippines

Philippine Children's Medical Center, Quezon 1104, Philippines

Quezon City General Hospital, Quezon, Philippines

Additional Information

Starting date: May 2002
Last updated: October 28, 2013

Page last updated: August 23, 2015

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