Clinical trial NCT00163462: Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Official title: Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
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: 750
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 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 once daily, using one of the two dose levels; 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
measure: PD20FEV1 from methacholine challenge.
Secondary outcomes:
measure: FEV1 as % of predicted
measure: PEF from spirometry
measure: morning and evening PEF from diary
measure: asthma symptom score from diary
measure: salbutamol MDI use from diary
measure: diurnal PEF fluctuation from diary
measure: dropout rate due to asthma exacerbations and time to the first asthma exacerbation
measure: percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
measure: onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
measure: interview administered PAQLQ(S), self-administered PACQLQ
measure: physical examination and vital signs
measure: laboratory investigation
measure: AEs
measure: HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
Other outcomes:
Locations:
city: Campinas - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Curitiba-PR
country: Brazil
facility: Altana Pharma/Nycomed
city: Florianópolis-SC
country: Brazil
facility: Altana Pharma/Nycomed
city: Porto Alegre-RS
country: Brazil
facility: Altana Pharma/Nycomed
city: Porto Alegre-RS
country: Brazil
facility: Altana Pharma/Nycomed
city: Rio de Janeiro-RJ
country: Brazil
facility: Altana Pharma/Nycomed
city: Salvador - Bahia
country: Brazil
facility: Altana Pharma/Nycomed
city: Santo André-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: São Paulo-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: São Paulo-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Frankfurt
country: Germany
facility: Altana Pharma/Nycomed
city: Gaißach bei Bad Tölz
country: Germany
facility: Altana Pharma/Nycomed
city: Geesthacht
country: Germany
facility: Altana Pharma/Nycomed
city: Mainz
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Wesel
country: Germany
facility: Altana Pharma/Nycomed
city: Wiefelstede
country: Germany
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Debrecen
country: Hungary
facility: Altana Pharma/Nycomed
city: Jaszbereny
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosdos
country: Hungary
facility: Altana Pharma/Nycomed
city: Pecs
country: Hungary
facility: Altana Pharma/Nycomed
city: Törökbalint
country: Hungary
facility: Altana Pharma/Nycomed
city: Inowroclaw
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed
city: Rzeszow
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Zawadzkie
country: Poland
facility: Altana Pharma/Nycomed
city: Amadora
country: Portugal
facility: Altana Pharma/Nycomed
city: Faro
country: Portugal
facility: Altana Pharma/Nycomed
city: Guimaraes
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Matosinhos
country: Portugal
facility: Altana Pharma/Nycomed
city: Oliveira de Azemeis
country: Portugal
facility: Altana Pharma/Nycomed
city: Porto
country: Portugal
facility: Altana Pharma/Nycomed
city: Porto
country: Portugal
facility: Altana Pharma/Nycomed
city: Setúbal
country: Portugal
facility: Altana Pharma/Nycomed
city: Viana do Castelo
country: Portugal
facility: Altana Pharma/Nycomed
city: Vila Nova de Gaia
country: Portugal
facility: Altana Pharma/Nycomed
city: Bellville - Cape Town -
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Morningside, Sandton
country: South Africa
facility: Altana Pharma/Nycomed
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama / RSA-Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Westville
country: South Africa
facility: Altana Pharma/Nycomed
city: Wynberg
country: South Africa
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: