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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00163332
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. AUC(0-24h)/24 h of serum cortisol level
  2. 24 h urinary cortisol excretion adjusted for creatinine.

Secondary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163332


Locations
Belgium
Altana Pharma/Nycomed
Genk, Belgium, 3600
Altana Pharma/Nycomed
Ghent, Belgium, 9000
Altana Pharma/Nycomed
Lanaken, Belgium, 3620
Altana Pharma/Nycomed
Liege, Belgium, 4000
Altana Pharma/Nycomed
Liége, Belgium, 4000
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163332     History of Changes
Other Study ID Numbers: BY9010/M1-129
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Asthma
Ciclesonide
Fluticasone propionate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ciclesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists