Clinical trial NCT00273962: A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-10
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment
Secondary outcomes:
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
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Jose Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Marikina
country: Philippines
facility: Amang Rodriguez Hospital
city: Pasay
country: Philippines
facility: San Juan de Dios Hospital
city: Pasig
country: Philippines
facility: Rizal Provincial Hospital
city: Quezon City
country: Philippines
facility: East Ave Medical Center
city: Quezon City
country: Philippines
facility: Philipines Heart Center
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Quezon
country: Philippines
facility: Philippine Children's Medical Center
city: Quezon
country: Philippines
facility: Quezon City General Hospital
Study officials:
affiliation: B.I. (Phil) Inc.
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: