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

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. Identifier: NCT00163423
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : November 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. FEV1
  2. time to the first asthma exacerbation.

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00163423

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Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00163423     History of Changes
Other Study ID Numbers: BY9010/M1-142
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by AstraZeneca:
Fluticasone propionate

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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
Hormones, Hormone Substitutes, and Hormone Antagonists