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

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ClinicalTrials.gov Identifier: NCT00273962
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : October 29, 2013
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Asthma Drug: ipratropium plus salbutamol UDV Drug: salbutamol UDV Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
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
Study Start Date : May 2002
Primary Completion Date : November 2003
Estimated Study Completion Date : November 2003


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273962


Locations
Philippines
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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. (Phil) Inc.
More Information

ClinicalTrials.gov Identifier: NCT00273962     History of Changes
Other Study ID Numbers: 1012.45
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Albuterol
Ipratropium
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