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Completed

NCT Number: NCT00163462

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

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.

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Key information

Conditions

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

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Campinas - SP, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

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

Main Exclusion Criteria:

  • 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

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

  1. FEV1 absolute values

  2. PD20FEV1 from methacholine challenge.

Secondary outcomes

  1. FEV1 as % of predicted

  2. PEF from spirometry

  3. morning and evening PEF from diary

  4. asthma symptom score from diary

  5. salbutamol MDI use from diary

  6. diurnal PEF fluctuation from diary

  7. dropout rate due to asthma exacerbations and time to the first asthma exacerbation

  8. percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control

  9. onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication

  10. interview administered PAQLQ(S), self-administered PACQLQ

  11. physical examination and vital signs

  12. laboratory investigation

  13. AEs

  14. HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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