Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

NCT00163449 | Completed Phase 3

• 1 other identifier: BY9010/M1-207
• Study Type: interventional
• Target: 1,000
• Locations: 9 countries
• Sites: 96

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.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; Child; Pediatric

Outcome Measures

Primary Outcomes (1)

• time to first moderate or severe asthma exacerbation.

  24 weeks

Secondary Outcomes (18)

• rate of patients with moderate or severe asthma exacerbation

  24 weeks

• rate of patients with moderate asthma exacerbation

  24 weeks

• rate of patients with severe asthma exacerbation

  24 weeks

• time to first moderate asthma exacerbation

  24 weeks

• time to first severe asthma exacerbation

  24 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

Ciclesonide 40 µg

Drug: Ciclesonide

2

ACTIVE COMPARATOR

Ciclesonide 80 µg

Drug: Ciclesonide

3

ACTIVE COMPARATOR

Ciclesonide 160 µg

Drug: Ciclesonide

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ciclesonide DRUG

Efficacy and Safety of Ciclesonide

1; 2; 3

Placebo DRUG

Placebo

4

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (96)

Altana Pharma/Nycomed

Campinas - SP, 13081970, Brazil

Location

Altana Pharma/Nycomed

Curitiba-PR, 80060900, Brazil

Location

Altana Pharma/Nycomed

Paraná, 80060900, Brazil

Location

Altana Pharma/Nycomed

Pinheiros Sao Paulo - SP, 1246-000, Brazil

Location

Altana Pharma/Nycomed

Porto Alegre-RS, 90035003, Brazil

Location

Altana Pharma/Nycomed

Porto Alegre-RS, 90610000, Brazil

Location

Altana Pharma/Nycomed

Recife-PE, 50670901, Brazil

Location

Altana Pharma/Nycomed

Rio de Janeiro-RJ, 21941590, Brazil

Location

Altana Pharma/Nycomed

Rio Grande, 90610000, Brazil

Location

Altana Pharma/Nycomed

Salvador - Bahia, 41920000, Brazil

Location

Altana Pharma/Nycomed

Santo André-SP, 9060650, Brazil

Location

Altana Pharma/Nycomed

Sao Paulo - SP, 5437000, Brazil

Location

Altana Pharma/Nycomed

Sao Paulo-SP, 4025002, Brazil

Location

Altana Pharma/Nycomed

São Paulo, 1277900, Brazil

Location

Altana Pharma/Nycomed

São Paulo, 5403900, Brazil

Location

Altana Pharma/Nycomed

São Paulo, 5651, Brazil

Location

Altana Pharma/Nycomed

São Paulo, Brazil

Location

Altana Pharma/Nycomed

São Paulo-SP, 1221020, Brazil

Location

Altana Pharma/Nycomed

Berlin, 13353, Germany

Location

Altana Pharma/Nycomed

Cologne, 50924, Germany

Location

Altana Pharma/Nycomed

Dresden, 1307, Germany

Location

Altana Pharma/Nycomed

Düsseldorf, 40225, Germany

Location

Altana Pharma/Nycomed

Frankfurt, 60590, Germany

Location

Altana Pharma/Nycomed

Heidelberg, 69120, Germany

Location

Altana Pharma/Nycomed

Mannheim, 68167, Germany

Location

Altana Pharma/Nycomed

München, 80939, Germany

Location

Altana Pharma/Nycomed

Rosenheim, 83026, Germany

Location

Altana Pharma/Nycomed

Wesel, 46483, Germany

Location

Altana Pharma/Nycomed

Wiefelstede, 26215, Germany

Location

Altana Pharma/Nycomed

Baja, 6500, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1083, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1089, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1121, Hungary

Location

Altana Pharma/Nycomed

Debrecen, 4012, Hungary

Location

Altana Pharma/Nycomed

Jászberény, 5100, Hungary

Location

Altana Pharma/Nycomed

Kaposvár, 7400, Hungary

Location

Altana Pharma/Nycomed

Kiskunhalas, 6400, Hungary

Location

Altana Pharma/Nycomed

Miskolc, 3501, Hungary

Location

Altana Pharma/Nycomed

Mosdós, 7257, Hungary

Location

Altana Pharma/Nycomed

Mosonmagyaróvár, 9200, Hungary

Location

Altana Pharma/Nycomed

Nyíregyháza, 4400, Hungary

Location

Altana Pharma/Nycomed

Pécs, 7624, Hungary

Location

Altana Pharma/Nycomed

Szeged, 6720, Hungary

Location

Altana Pharma/Nycomed

Szekszárd, 7100, Hungary

Location

Altana Pharma/Nycomed

Törökbálint, 2045, Hungary

Location

Altana Pharma/Nycomed

Chandanwadi, Thane, 400061, India

Location

Altana Pharma/Nycomed

Chennai, 600 034, India

Location

Altana Pharma/Nycomed

Coimbatore, 641 014, India

Location

Altana Pharma/Nycomed

Coimbatore, 641004, India

Location

Altana Pharma/Nycomed

Coimbatore, Tamilnadu, 641 044, India

Location

Altana Pharma/Nycomed

Kalaburagi, 585104, India

Location

Altana Pharma/Nycomed

Mumbai, 400 004, India

Location

Altana Pharma/Nycomed

Mumbai, 400008, India

Location

Altana Pharma/Nycomed

Mumbai, Dadar (E), 400 014, India

Location

Altana Pharma/Nycomed

Nagpur, 12, India

Location

Altana Pharma/Nycomed

Noida, 201301, India

Location

Altana Pharma/Nycomed

Pune, 411 001, India

Location

Altana Pharma/Nycomed

Pune, 411 033, India

Location

Altana Pharma/Nycomed

Eindhoven, 5623 EJ, Netherlands

Location

Altana Pharma/Nycomed

Enschede, 7511 JX, Netherlands

Location

Altana Pharma/Nycomed

Hoofddorp, 2134 TM, Netherlands

Location

Altana Pharma/Nycomed

Leeuwarden, 8901 BR, Netherlands

Location

Altana Pharma/Nycomed

Nijmegen, 6532 SZ, Netherlands

Location

Altana Pharma/Nycomed

Zwolle, 8025 AB, Netherlands

Location

Altana Pharma/Nycomed

Karpacz, 58-540, Poland

Location

Altana Pharma/Nycomed

Lublin, 20-093, Poland

Location

Altana Pharma/Nycomed

Opole, 45401, Poland

Location

Altana Pharma/Nycomed

Poznan, 60-214, Poland

Location

Altana Pharma/Nycomed

Poznan, 60-693, Poland

Location

Altana Pharma/Nycomed

Zawadzkie, 46-059, Poland

Location

Altana Pharma/Nycomed

Bellville - Cape Town -, 7530, South Africa

Location

Altana Pharma/Nycomed

Cape Town, 7937, South Africa

Location

Altana Pharma/Nycomed

Durban, 3630, South Africa

Location

Altana Pharma/Nycomed

Morningside, Sandton, 2196, South Africa

Location

Altana Pharma/Nycomed

Mowbray, Cape Town, 7925, South Africa

Location

Altana Pharma/Nycomed

New Redruth, Alberton, 1450, South Africa

Location

Altana Pharma/Nycomed

Overport, Durban, 4091, South Africa

Location

Altana Pharma/Nycomed

Panorama / RSA-Cape Town, 7500, South Africa

Location

Altana Pharma/Nycomed

Pietermaritzburg, 3201, South Africa

Location

Altana Pharma/Nycomed

Westville, 3630, South Africa

Location

Altana Pharma/Nycomed

Wynberg, 7945, South Africa

Location

Altana Pharma/Nycomed

Barcelona, 8003, Spain

Location

Altana Pharma/Nycomed

Barcelona, 8023, Spain

Location

Altana Pharma/Nycomed

Barcelona, 8222, Spain

Location

Altana Pharma/Nycomed

El Palmar (Murcia), 30120, Spain

Location

Altana Pharma/Nycomed

Elche - Alicante, 3203, Spain

Location

Altana Pharma/Nycomed

Leganes (Madrid), 28911, Spain

Location

Altana Pharma/Nycomed

Madrid, 28006, Spain

Location

Altana Pharma/Nycomed

Madrid, 28009, Spain

Location

Altana Pharma/Nycomed

Madrid, 28041, Spain

Location

Altana Pharma/Nycomed

Sabadell, 8208, Spain

Location

Altana Pharma/Nycomed

Seville, 41071, Spain

Location

Altana Pharma/Nycomed

Valencia, 46009, Spain

Location

Altana Pharma/Nycomed

Lausanne, 1011, Switzerland

Location

Altana Pharma/Nycomed

Trimbach, 4632, Switzerland

Location

Altana Pharma/Nycomed

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 21839625 DERIVED

Related Links

• BY9010-M1-207-DEU RDS-2008-03-20.pdf

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: May 1, 2007
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

IN (13); HU (16); ES (12); CH (3); DE (11); NL (6); BR (18); ZA (11); PL (6)