Phase 4
N=60
Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Acute Bronchial Obstruction, Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00460577 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation — 44; 43.67 Liters/minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Formoterol fumerate (Drug); fenoterol/ipratropium bromide (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation |
44; 43.67 | — |
| PRIMARY Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation |
0.32; 0.34 | — |
| PRIMARY Mean Change in Pulse Oxymetry From Baseline to Final Evaluation |
2.57; 2.83 | — |
| PRIMARY Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation |
-3.18; -3.04 | — |
| SECONDARY Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events |
— | — |
| SECONDARY Pharmacoeconomic Analysis |
9.21; 25.67 | — |
Summary
To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute bronchial obstruction attending emergency services
Eligibility Criteria
Inclusion Criteria
- Asthmatic children 5- 38.5°C axillar temp)
- Patients with any clinical significance condition
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00460577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.