Evaluation of Safety and Efficacy of Symbicort pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide/formoterol pMDI 40/2.25ug + spacer (Drug); Budesonide/formoterol pMDI 40/2.25 ug (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Tomas Anderson, MD PhD, Study Director, Affiliation: AstraZeneca
Piotr Kuna, MD PhD, Principal Investigator, Affiliation: Uniwersytecki Spital
Summary
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of
steroid potency, improvement of lung function and asthma symptoms in children with asthma
(6-11 years).
Clinical Details
Official title: A 4-Week, Open-Label, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome variable will be 24-hour urinary free cortisol (UFC) excretion at the end of the treatment period
Secondary outcome: Efficacy variables will be spirometry measurements at clinic visits, morning & evening Peak Expiratory Flow (PEF), asthma symptoms, night-time awakenings due to asthma & use of reliever medication recorded in daily diary.
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- children 6-11 years, diagnosed asthma treated
- 6 months, PEF
- 50% of predicted normal value pre-bronchodilator
Exclusion Criteria:
- current systemic glucocorticosteroids usage
- current respiratory infection
- any significant disease or disorder as judged by investigator
Locations and Contacts
Research Site, Budapest, Hungary
Research Site, Debrecen, Hungary
Research Site, Kaposvar, Hungary
Research Site, Biaystok, Poland
Research Site, Bydgoszcz, Poland
Research Site, Bytom, Poland
Research Site, Karpacz, Poland
Research Site, Krakow, Poland
Research Site, Od, Poland
Research Site, Warszawa, Poland
Research Site, Moscow, Russian Federation
Additional Information
Starting date: September 2007
Last updated: March 28, 2008
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