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

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: January 9, 2006
Last updated: October 28, 2013
Last verified: October 2013
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
Intervention Model: Parallel Assignment
Masking: Double
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.


Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone given every 20 minutes for 3 doses


Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.


  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
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Please refer to this study by its identifier: NCT00273962

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, Philippines, 1104
Quezon City General Hospital
Quezon, Philippines
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator B.I. (Phil) Inc.
  More Information Identifier: NCT00273962     History of Changes
Other Study ID Numbers: 1012.45
Study First Received: January 9, 2006
Last Updated: October 28, 2013

Additional relevant MeSH terms:
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents processed this record on September 19, 2017