A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00273962

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Ipratropium Ipratropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combivent UDV vs. Salbutamol UDV (2.5mg) for Treatment of an Acute Exacerbation of Asthma in Children

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Estimated Enrollment:	490
Study Start Date:	May 2002
Estimated Study Completion Date:	November 2003

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

All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation.
Male or female patients 2 to 10 years of age.
Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial.

EXCLUSION CRITERIA

Patients with known or suspected hypersensitivity to study drugs
Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications
Patients with first wheezing episode only
Prior intubation for asthma for more than 24 hours
Patients who used ipratropium within six hours prior to consultation
Patients with concurrent stridor or possible presence of intra-thoracic foreign body
Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease)
Patients requiring immediate resuscitation or airway intervention
With psychiatric disease or psychosocial problems
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
Philipines Heart Center
Quezon City, Philippines
San Juan de Dios Hospital
Pasay, Philippines
Philippine Children's Medical Center
Quezon, Philippines, 1104
Philippine General Hospital
Manila, Philippines
Rizal Provincial Hospital
Pasig, Philippines
Quirino Memorial Medical Center
Quezon City, Philippines
Amang Rodriguez Hospital
Marikina, Philippines
Quezon City General Hospital
Quezon, Philippines
East Ave Medical Center
Quezon City, Philippines
Jose Reyes Memorial Medical Center
Manila, Philippines

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. (Phil) Inc.

More Information

Study ID Numbers:	1012.45
Study First Received:	January 9, 2006
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00273962
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Ipratropium
Respiratory Tract Diseases
Lung Diseases

Albuterol
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents

Reproductive Control Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009