Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

NCT00163462 | Completed Phase 3

• 1 other identifier: BY9010/M1-206
• Study Type: interventional
• Target: 750
• Locations: 6 countries
• Sites: 57

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.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; Child; Fluticasone propionate; Pediatric

Outcome Measures

Primary Outcomes (2)

• FEV1 absolute values

• PD20FEV1 from methacholine challenge.

Secondary Outcomes (14)

• FEV1 as % of predicted

• PEF from spirometry

• morning and evening PEF from diary

• asthma symptom score from diary

• salbutamol MDI use from diary

Interventions

Ciclesonide DRUG

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (57)

Altana Pharma/Nycomed

Campinas - SP, 13081970, Brazil

Location

Altana Pharma/Nycomed

Curitiba-PR, 80060900, Brazil

Location

Altana Pharma/Nycomed

Florianópolis-SC, 88040970, Brazil

Location

Altana Pharma/Nycomed

Porto Alegre-RS, 90035003, Brazil

Location

Altana Pharma/Nycomed

Porto Alegre-RS, 90610000, Brazil

Location

Altana Pharma/Nycomed

Rio de Janeiro-RJ, 21941590, 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-SP, 1221020, Brazil

Location

Altana Pharma/Nycomed

São Paulo-SP, 5403900, Brazil

Location

Altana Pharma/Nycomed

Frankfurt, 60590, Germany

Location

Altana Pharma/Nycomed

Gaißach Bei Bad Tölz, 83674, Germany

Location

Altana Pharma/Nycomed

Geesthacht, 21502, Germany

Location

Altana Pharma/Nycomed

Mainz, 55101, Germany

Location

Altana Pharma/Nycomed

München, 80337, Germany

Location

Altana Pharma/Nycomed

München, 80939, Germany

Location

Altana Pharma/Nycomed

Wesel, 46483, Germany

Location

Altana Pharma/Nycomed

Wiefelstede, 26215, Germany

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

Miskolc, 3501, Hungary

Location

Altana Pharma/Nycomed

Mosdós, 7257, Hungary

Location

Altana Pharma/Nycomed

Pécs, 7624, Hungary

Location

Altana Pharma/Nycomed

Törökbálint, 2045, Hungary

Location

Altana Pharma/Nycomed

Inowrocław, 88-100, Poland

Location

Altana Pharma/Nycomed

Lodz, 90-141, Poland

Location

Altana Pharma/Nycomed

Lublin, 20-093, Poland

Location

Altana Pharma/Nycomed

Poznan, 60-214, Poland

Location

Altana Pharma/Nycomed

Rzeszów, 35-301, Poland

Location

Altana Pharma/Nycomed

Warsaw, 01-211, Poland

Location

Altana Pharma/Nycomed

Warsaw, 03-924, Poland

Location

Altana Pharma/Nycomed

Zawadzkie, 46-059, Poland

Location

Altana Pharma/Nycomed

Amadora, 2720276, Portugal

Location

Altana Pharma/Nycomed

Faro, 8000-386, Portugal

Location

Altana Pharma/Nycomed

Guimarães, 4800055, Portugal

Location

Altana Pharma/Nycomed

Lisbon, 1269-098, Portugal

Location

Altana Pharma/Nycomed

Lisbon, 1649035, Portugal

Location

Altana Pharma/Nycomed

Lisbon, 1990050, Portugal

Location

Altana Pharma/Nycomed

Matosinhos Municipality, 4450024, Portugal

Location

Altana Pharma/Nycomed

Oliveira de Azeméis, 3720000, Portugal

Location

Altana Pharma/Nycomed

Porto, 4099-001, Portugal

Location

Altana Pharma/Nycomed

Porto, 4200319, Portugal

Location

Altana Pharma/Nycomed

Setúbal, 2910446, Portugal

Location

Altana Pharma/Nycomed

Viana do Castelo, 4901858, Portugal

Location

Altana Pharma/Nycomed

Vila Nova de Gaia, 4400-123, Portugal

Location

Altana Pharma/Nycomed

Bellville - Cape Town -, 7530, South Africa

Location

Altana Pharma/Nycomed

Cape Town, 7937, 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

Panorama / RSA-Cape Town, 7500, South Africa

Location

Altana Pharma/Nycomed

Westville, 3630, South Africa

Location

Altana Pharma/Nycomed

Wynberg, 7945, South Africa

Location

Related Links

• BY9010-MI-206-RDS-2006-09-01.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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: October 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: December 5, 2016

Record last verified: 2016-10

Locations

DE (8); BR (12); HU (9); PL (8); ZA (7); PT (13)