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NCT Number: NCT00163423

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; 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 (24 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

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Gmünd, Austria

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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:

  • Outpatients
  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Good health with the exception of asthma
  • Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
  • FEV1 80 - 105% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Current smoking with more than 10 pack-years
  • Previous smoking with more than 10 pack-years
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
  • 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

  2. time to the first asthma exacerbation.

Secondary outcomes

  1. FVC

  2. asthma symptom score

  3. use of rescue medication

  4. AQLQ(S) and EQ-5D

  5. percentage of days on which patients perceived asthma control

  6. percentage of nocturnal awakening-free days

  7. percentage of rescue medication-free days

  8. percentage of asthma symptom-free days

  9. physical examination

  10. vital signs

  11. standard laboratory work-up

  12. adverse events

  13. number of patients with local oropharyngeal adverse events.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 8, 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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