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Completed

NCT Number: NCT00163319

Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Brussels, Belgium

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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:

  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
  • FEV1 ≥ 80% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
  • COPD
  • Smoking with ≥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. number of patients with candidiasis of the oropharynx or hoarseness.

Secondary outcomes

  1. inhaled Corticosteroids Questionnaire (ICQ)

  2. proportion of cases of candidiasis of the oropharynx or

  3. hoarseness at each visit Secondary variables

  4. FEV1, FVC, PEF from spirometry

  5. morning and evening PEF from diaries

  6. diurnal PEF fluctuation

  7. onset of treatment effect

  8. percent days on which patient perceived asthma control

  9. percent of nocturnal awakening-free days

  10. percent of rescue medication free days

  11. percent symptom free days

  12. asthma symptom score

  13. use of rescue medication

  14. time to first asthma exacerbation

  15. number of patients with an asthma exacerbation

  16. AQLQ

  17. number of patients with candidiasis of the oropharynx or hoarseness by severity

  18. physical examination, ECG

  19. vital sings

  20. adverse events

  21. standard laboratory work-up

  22. morning serum cortisol

  23. skin bruising.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma

Important dates

Study start
2004
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Dec 2, 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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