Comparison of ciclesonide (80 µg or 160 µg once daily in the evening) and fluticasone propionate (100 µg twice daily in the morning and evening) in pediatric asthma patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000825-31-HU

Enrollment

750

Registered

2004-09-29

Start date

2004-10-08

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchial asthma MedDRA version: 5.1 Level: llt Classification code 10003553

Interventions

Trade Name: ALVESCO 40 Inhaler Product Name: ALVESCO 40 Inhaler Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: Ciclesonide Current Sponsor code: BY9010 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 6 to 11 years - persistent bronchial asthma for at least 6 months - FEV1of 50 to 90% for patients using rescue medication only, 80 to 100% for patients using ICS, 50 to 100% for patients using non-ICS controller drugs - FEV1 of 50 to 90% of predicted after baseline (at randomization) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids - COPD - History of life-threatening asthma - Two or more inpatient hospitalizations for asthma within the last year - Asthma exacerbation within the last 30 days - Current smoking - Use of systemic steroids during the study, within the last 30 days, or for more than 60 days within the last 2 years - Use of ICS within the last 30 days prior to B0 at doses higher than 200 µg/day FP (CFC/HFA) or equivalent - Use of a combination of ICS and other asthma controller drugs within the last 30 days prior to B0 - Pregnancy - Premature birth

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the efficacy of ciclesonide and fluticasone propionate in pediatric asthma patients;Secondary Objective: Further study dose response, safety and tolerability of ciclesonide in children;Primary end point(s): FEV1 absolute values (T12/Tend compared to T0)	—

Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026