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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: ipratropium plus salbutamol UDV; Drug: salbutamol UDV

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

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines
    • Philippine General Hospital
  • Manila, Philippines
    • Jose Reyes Memorial Medical Center
  • Marikina, Philippines
    • Amang Rodriguez Hospital
  • Pasay, Philippines
    • San Juan de Dios Hospital
  • Pasig, Philippines
    • Rizal Provincial Hospital
  • Quezon, Philippines, 1104
    • Philippine Children's Medical Center
  • Quezon, Philippines
    • Quezon City General Hospital
  • Quezon City, Philippines
    • East Ave Medical Center
  • Quezon City, Philippines
    • Philipines Heart Center
  • Quezon City, Philippines
    • Quirino Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim Study Coordinator, B.I. (Phil) Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): November 1, 2003
• Study Completion: November 1, 2003

Study Registration Dates

• First Submitted: January 9, 2006
• First Submitted That Met QC Criteria: January 9, 2006
• First Posted (Estimate): January 10, 2006

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 28, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Ipratropium
• Other Study ID Numbers: 1012.45