A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
NCT ID: NCT00273962
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2002-05-31
2003-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ipratropium plus salbutamol UDV
salbutamol UDV
Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
10 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. (Phil) Inc.
Locations
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Jose Reyes Memorial Medical Center
Manila, , Philippines
Philippine General Hospital
Manila, , Philippines
Amang Rodriguez Hospital
Marikina City, , Philippines
San Juan de Dios Hospital
Pasay, , Philippines
Rizal Provincial Hospital
Pasig, , Philippines
Philippine Children's Medical Center
Quezon, , Philippines
Quezon City General Hospital
Quezon, , Philippines
East Ave Medical Center
Quezon City, , Philippines
Philipines Heart Center
Quezon City, , Philippines
Quirino Memorial Medical Center
Quezon City, , Philippines
Countries
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Other Identifiers
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1012.45
Identifier Type: -
Identifier Source: org_study_id