Clinical trial NCT00163449: Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
Official title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Child
Pediatric
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent by the parents or legal guardians of the patient
* Outpatients
* Good health with the exception of asthma
* Documented diagnosis of asthma for more than 6 months
* Use of rescue medication only or pretreatment with a controller drug

Main Exclusion Criteria:

* Concomitant severe diseases
* Diseases contraindicated for the use of inhaled steroids
* Other relevant lung diseases causing impairment in pulmonary function
* Recurrent, episodic wheezing only
* History of life-threatening asthma
* History of any mechanical ventilation
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Premature birth (\< 32 weeks gestation)

Primary outcomes:
measure: time to first moderate or severe asthma exacerbation.
timeFrame: 24 weeks
Secondary outcomes:
measure: rate of patients with moderate or severe asthma exacerbation
timeFrame: 24 weeks
measure: rate of patients with moderate asthma exacerbation
timeFrame: 24 weeks
measure: rate of patients with severe asthma exacerbation
timeFrame: 24 weeks
measure: time to first moderate asthma exacerbation
timeFrame: 24 weeks
measure: time to first severe asthma exacerbation
timeFrame: 24 weeks
measure: asthma symptom score from diary
timeFrame: 24 weeks
measure: use of rescue medication
timeFrame: 24 weeks
measure: patient perceived asthma control
timeFrame: 24 weeks
measure: quality of life data (PACQLQ)
timeFrame: 24 weeks
measure: morning and evening PEF from diary
timeFrame: 24 weeks
measure: pulmonary function variables measured at the investigational sites
timeFrame: 24 weeks
measure: adverse events
timeFrame: 24 weeks
measure: physical examination
timeFrame: 24 weeks
measure: vital signs
timeFrame: 24 weeks
measure: laboratory work-up
timeFrame: 24 weeks
measure: serum cortisol
timeFrame: 24 weeks
measure: urine cortisol variables
timeFrame: 24 weeks
measure: body growth determined by stadiometry.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Campinas - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Curitiba-PR
country: Brazil
facility: Altana Pharma/Nycomed
city: Paraná
country: Brazil
facility: Altana Pharma/Nycomed
city: Pinheiros Sao Paulo - SP
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: Recife-PE
country: Brazil
facility: Altana Pharma/Nycomed
city: Rio de Janeiro-RJ
country: Brazil
facility: Altana Pharma/Nycomed
city: Rio Grande
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: Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: São Paulo-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Dresden
country: Germany
facility: Altana Pharma/Nycomed
city: Düsseldorf
country: Germany
facility: Altana Pharma/Nycomed
city: Frankfurt
country: Germany
facility: Altana Pharma/Nycomed
city: Heidelberg
country: Germany
facility: Altana Pharma/Nycomed
city: Köln
country: Germany
facility: Altana Pharma/Nycomed
city: Mannheim
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Rosenheim
country: Germany
facility: Altana Pharma/Nycomed
city: Wesel
country: Germany
facility: Altana Pharma/Nycomed
city: Wiefelstede
country: Germany
facility: Altana Pharma/Nycomed
city: Baja
country: Hungary
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: Kaposvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Kiskunhalas
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosdós
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosonmagyaróvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Nyíregyháza
country: Hungary
facility: Altana Pharma/Nycomed
city: Pecs
country: Hungary
facility: Altana Pharma/Nycomed
city: Szeged
country: Hungary
facility: Altana Pharma/Nycomed
city: Szekszárd
country: Hungary
facility: Altana Pharma/Nycomed
city: Törökbalint
country: Hungary
facility: Altana Pharma/Nycomed
city: Chandanwadi, Thane
country: India
facility: Altana Pharma/Nycomed
city: Chennai
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: Gulbarga
country: India
facility: Altana Pharma/Nycomed
city: Mumbai, Dadar (E)
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Nagpur
country: India
facility: Altana Pharma/Nycomed
city: Noida
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Eindhoven
country: Netherlands
facility: Altana Pharma/Nycomed
city: Enschede
country: Netherlands
facility: Altana Pharma/Nycomed
city: Hoofddorp
country: Netherlands
facility: Altana Pharma/Nycomed
city: Leeuwarden
country: Netherlands
facility: Altana Pharma/Nycomed
city: Nijmegen
country: Netherlands
facility: Altana Pharma/Nycomed
city: Zwolle
country: Netherlands
facility: Altana Pharma/Nycomed
city: Karpacz
country: Poland
facility: Altana Pharma/Nycomed
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed
city: Opole
country: Poland
facility: Altana Pharma/Nycomed
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed
city: Zawadzkie
country: Poland
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: Durban
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: New Redruth, Alberton
country: South Africa
facility: Altana Pharma/Nycomed
city: Overport, Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama / RSA-Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Pietermaritzburg
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
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: El Palmar (Murcia)
country: Spain
facility: Altana Pharma/Nycomed
city: Elche - Alicante
country: Spain
facility: Altana Pharma/Nycomed
city: Leganes (Madrid)
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Sabadell
country: Spain
facility: Altana Pharma/Nycomed
city: Sevilla
country: Spain
facility: Altana Pharma/Nycomed
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed
city: Lausanne
country: Switzerland
facility: Altana Pharma/Nycomed
city: Trimbach
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Brand PL, Luz Garcia-Garcia M, Morison A, Vermeulen JH, Weber HC. Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy. Respir Med. 2011 Nov;105(11):1588-95. doi: 10.1016/j.rmed.2011.07.017. Epub 2011 Aug 11.