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Completed

NCT Number: NCT00163332

Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Genk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Patients who have had a history of bronchial asthma for at least 6 months
  • FEV1 >60% of predicted for at least 24 h
  • Patients who are hyperresponsive to methacholine and to AMP
  • Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Patients suffering from COPD and/or other relevant lung diseases except asthma
  • Current smokers and ex-smokers both with ≥10 pack years

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

  1. AUC(0-24h)/24 h of serum cortisol level

  2. 24 h urinary cortisol excretion adjusted for creatinine.

Secondary outcomes

  1. 8 am measurement of bone formation markers

  2. PC20FEV1 to methacholine

  3. PC20FEV1 to AMP

  4. lung function (FEV1, FVC)

  5. pharmacokinetics

  6. safety and tolerability.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma

Important dates

Study start
2003
First posted
Sep 14, 2005
Registry last updated
Dec 6, 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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