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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00273962
First received: January 9, 2006
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: ipratropium plus salbutamol UDV
Drug: salbutamol UDV
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 500
Study Start Date: May 2002
Estimated Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273962

Locations
Philippines
Philippine General Hospital
Manila, Philippines
Jose Reyes Memorial Medical Center
Manila, Philippines
Amang Rodriguez Hospital
Marikina, Philippines
San Juan de Dios Hospital
Pasay, Philippines
Rizal Provincial Hospital
Pasig, Philippines
Philippine Children's Medical Center
Quezon, Philippines, 1104
Quezon City General Hospital
Quezon, Philippines
Philipines Heart Center
Quezon City, Philippines
East Ave Medical Center
Quezon City, Philippines
Quirino Memorial Medical Center
Quezon City, Philippines
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. (Phil) Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273962     History of Changes
Other Study ID Numbers: 1012.45
Study First Received: January 9, 2006
Last Updated: October 28, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Ipratropium
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014