Clinical trial NCT00536913: Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Symbicort pMDI
spacer
children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 107
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Urinary Free Cortisol (UFC)
timeFrame: At baseline and 4 weeks
Secondary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: At baseline, at 2 weeks and 4 weeks
measure: Morning Peak Expiratory Flow (mPEF)
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Evening Peak Expiratory Flow (ePEF)
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Asthma Symptoms at Night
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Asthma Symptoms at Day
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Percentage of Nights With Awakenings Due to Asthma
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Use of Rescue Medication at Night
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
measure: Use of Rescue Medication at Day
timeFrame: Daily during run-in and daily during treatment period of 6 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Karpacz
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tomas Anderson, MD PhD
role: STUDY_DIRECTOR
affiliation: Uniwersytecki Spital
name: Piotr Kuna, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: