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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Further Study Details: 

Primary Outcomes: time to first moderate or severe asthma exacerbation.
Secondary Outcomes: rate of patients with moderate or severe asthma exacerbation; rate of patients with moderate asthma exacerbation; rate of patients with severe asthma exacerbation; time to first moderate asthma exacerbation; time to first severe asthma exacerbation; asthma symptom score from diary; use of rescue medication; patient perceived asthma control; quality of life data (PACQLQ); morning and evening PEF from diary; pulmonary function variables measured at the investigational sites; adverse events; physical examination; vital signs; laboratory work-up; serum cortisol; urine cortisol variables; body growth determined by stadiometry.
Expected Total Enrollment:  1000

Ages Eligible for Study:  2 Years   -   6 Years,  Genders Eligible for Study:  Both

Criteria

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

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00163449

Renate Engelstaetter, PhD       info.clintrials@altanapharma.com

Brazil
      ALTANA Investigational Site 6181, Santo André, São Paulo,  09060650,  Brazil
      ALTANA Investigational Site 6194, Salvador, Bahia,  41940060,  Brazil
      ALTANA Investigational Site 6200, Porto Alegre, Rio Grande do Sul,  90035003,  Brazil
      ALTANA Investigational Site 10058, Rio de Janeiro, Rio de Janeiro,  21941590,  Brazil
      ALTANA Investigational Site 10350, São Paulo, São Paulo,  05403900,  Brazil
      ALTANA Investigational Site 10351, São Paulo, São Paulo,  04025002,  Brazil
      ALTANA Investigational Site 10352, São Paulo, São Paulo,  01277900,  Brazil
      ALTANA Investigational Site 10353, São Paulo, São Paulo,  05437000,  Brazil
      ALTANA Investigational Site 10354, Campinas, São Paulo,  13081970,  Brazil
      ALTANA Investigational Site 10355, Curitiba, Paraná,  80060900,  Brazil
      ALTANA Investigational Site 10355, Paraná,  80060900,  Brazil
      ALTANA Investigational Site 10356, Porto Alegre, Rio Grande do Sul,  90610000,  Brazil
      ALTANA Investigational Site 10356, Rio Grande,  90610000,  Brazil
      ALTANA Investigational Site 10357, São Paulo, São Paulo,  05651,  Brazil
      ALTANA Investigational Site 12003, São Paulo, São Paulo,  Brazil
      ALTANA Investigational Site 12004, São Paulo, São Paulo,  05403900,  Brazil
      ALTANA Investigational Site 12006, Recife, Pernambuco,  50670901,  Brazil
Germany
      ALTANA Investigational Site 5949, Berlin,  13353,  Germany
      ALTANA Investigational Site 6180, Halle,  06120,  Germany
      ALTANA Investigational Site 6212, Wesel,  46483,  Germany
      ALTANA Investigational Site 7487, Mainz,  55101,  Germany
      ALTANA Investigational Site 7489, Frankfurt,  60590,  Germany
      ALTANA Investigational Site 7490, Mannheim,  68167,  Germany
      ALTANA Investigational Site 7494, München,  80939,  Germany
      ALTANA Investigational Site 7500, Wiefelstede,  26215,  Germany
      ALTANA Investigational Site 11727, Düsseldorf,  40225,  Germany
      ALTANA Investigational Site 11728, Köln,  50924,  Germany
      ALTANA Investigational Site 11729, Heidelberg,  69120,  Germany
      ALTANA Investigational Site 11730, Dresden,  01307,  Germany
      ALTANA Investigational Site 11732, Rosenheim,  83026,  Germany
      ALTANA Investigational Site 11745, Mannheim,  68167,  Germany
      ALTANA Investigational Site 11746, Leipzig,  04317,  Germany
Hungary
      ALTANA Investigational Site 6363, Pecs,  7624,  Hungary
      ALTANA Investigational Site 6368, Budapest,  1083,  Hungary
      ALTANA Investigational Site 6370, Mosdos,  7257,  Hungary
      ALTANA Investigational Site 6371, Törökbalint,  2045,  Hungary
      ALTANA Investigational Site 6372, Budapest,  1121,  Hungary
      ALTANA Investigational Site 6374, Debrecen,  4012,  Hungary
      ALTANA Investigational Site 6883, Nyíregyháza,  4400,  Hungary
      ALTANA Investigational Site 6886, Jaszbereny,  5100,  Hungary
      ALTANA Investigational Site 7169, Miskolc,  3501,  Hungary
      ALTANA Investigational Site 10053, Budapest,  1077,  Hungary
      ALTANA Investigational Site 11703, Mosonmagyaróvár,  9200,  Hungary
      ALTANA Investigational Site 11704, Szeged,  6720,  Hungary
      ALTANA Investigational Site 11705, Kaposvár,  7400,  Hungary
      ALTANA Investigational Site 11706, Szekszárd,  7100,  Hungary
      ALTANA Investigational Site 11707, Kiskunhalas,  76400,  Hungary
      ALTANA Investigational Site 11708, Baja,  6500,  Hungary
India
      ALTANA Investigational Site 6397, Mumbai,  400 004,  India
      ALTANA Investigational Site 6472, Pune,  411 033,  India
      ALTANA Investigational Site 6475, Chennai,  600 034,  India
      ALTANA Investigational Site 7154, Coimbatore, Tamilnadu,  641 044,  India
      ALTANA Investigational Site 8452, Coimbatore,  641 014,  India
      ALTANA Investigational Site 8460, Pune,  411 001,  India
      ALTANA Investigational Site 11995, Coimbatore,  641004,  India
      ALTANA Investigational Site 11996, Nagpur,  12,  India
      ALTANA Investigational Site 11997, Panchpakhadi, Thane,  India
      ALTANA Investigational Site 11998, Chandanwadi, Thane,  400061,  India
      ALTANA Investigational Site 11999, Gulbarga,  585104,  India
      ALTANA Investigational Site 12000, Mumbai,  400008,  India
Netherlands
      ALTANA Investigational Site 12033, Eindhoven,  5623 EJ,  Netherlands
      ALTANA Investigational Site 12034, Zwolle,  8025 AB,  Netherlands
      ALTANA Investigational Site 12035, Nijmegen,  6532 SZ,  Netherlands
      ALTANA Investigational Site 12036, ENSCHEDE,  7511 JX,  Netherlands
      ALTANA Investigational Site 12038, Hoofddorp,  2134 TM,  Netherlands
      ALTANA Investigational Site 12040, Leeuwarden,  8901 BR,  Netherlands
South Africa
      ALTANA Investigational Site 5234, Panorama / RSA-Cape Town,  7500,  South Africa
      ALTANA Investigational Site 6407, Wynberg,  7945,  South Africa
      ALTANA Investigational Site 6408, Bellville, Cape Town,  South Africa
      ALTANA Investigational Site 6416, Westville,  3630,  South Africa
      ALTANA Investigational Site 6419, Morningside, Sandton,  2196,  South Africa
      ALTANA Investigational Site 7842, Durban,  3630,  South Africa
      ALTANA Investigational Site 8990, Cape Town,  7937,  South Africa
      ALTANA Investigational Site 11963, Potchefstroom,  2531,  South Africa
      ALTANA Investigational Site 11965, Overport, Durban,  4091,  South Africa
      ALTANA Investigational Site 11966, New Redruth, Alberton,  1450,  South Africa
Spain
      ALTANA Investigational Site 3902, El Palmar, Murcia,  30120,  Spain
      ALTANA Investigational Site 6436, Leganes (Madrid),  28911,  Spain
      ALTANA Investigational Site 6438, Madrid,  28041,  Spain
      ALTANA Investigational Site 6443, Sevilla,  41071,  Spain
      ALTANA Investigational Site 6785, Barcelona,  08022,  Spain
      ALTANA Investigational Site 7845, Elche - Alicante,  03203,  Spain
      ALTANA Investigational Site 7846, Madrid,  28009,  Spain
      ALTANA Investigational Site 7850, Sabadell, Barcelona,  08208,  Spain
      ALTANA Investigational Site 9324, Madrid,  28006,  Spain
      ALTANA Investigational Site 10368, Valencia,  46009,  Spain
      ALTANA Investigational Site 11984, Barcelona,  08035,  Spain
      ALTANA Investigational Site 11986, Barcelona,  08003,  Spain
Switzerland
      ALTANA Investigational Site 11944, ZÜRICH,  8032,  Switzerland
      ALTANA Investigational Site 11978, Trimbach,  4632,  Switzerland
      ALTANA Investigational Site 11980, Lausanne,  1011,  Switzerland

Study chairs or principal investigators

Paul Brand, Dr,  Principal Investigator,  Isala Klinieken, Zwolle, The Netherlands   

Study ID Numbers:  BY9010/M1-207
Last Updated:  September 13, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00163449
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfArM)
ClinicalTrials.gov processed this record on 2005-09-20