Clinical trial NCT00163410: Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
Official title: A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* History of persistent bronchial asthma for at least 6 months
* FEV1 50-90% of predicted

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* History of life-threatening asthma
* Premature birth
* Current smoking
* Smoking history with either equal or more than 10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception

Primary outcomes:
measure: FEV1 absolute values.
Secondary outcomes:
measure: FEV1 as % of predicted
measure: PEF from spirometry
measure: diary based morning and evening PEF
measure: diary based symptom score
measure: diary based salbutamol MDI use
measure: diurnal PEF fluctuation
measure: drop-out rate due to asthma exacerbations
measure: time until asthma exacerbation
measure: number of symptom free- and rescue medication free days
measure: number of days with asthma control
measure: physical examination
measure: vital signs
measure: laboratory work-up
measure: adverse events.
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Altana Pharma/Nycomed
city: Bangalore
country: India
facility: Altana Pharma/Nycomed
city: Chandigarh
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore, Tamilnadu
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Delhi
country: India
facility: Altana Pharma/Nycomed
city: Kolkatta
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Shastri Nagar, Jaipur
country: India
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: