Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

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: NCT00163410
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 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, symptoms, and use of rescue medication in children with persistent 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 (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 Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
Study Start Date : April 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. FEV1 absolute values.

Secondary Outcome Measures :
  1. FEV1 as % of predicted
  2. PEF from spirometry
  3. diary based morning and evening PEF
  4. diary based symptom score
  5. diary based salbutamol MDI use
  6. diurnal PEF fluctuation
  7. drop-out rate due to asthma exacerbations
  8. time until asthma exacerbation
  9. number of symptom free- and rescue medication free days
  10. number of days with asthma control
  11. physical examination
  12. vital signs
  13. laboratory work-up
  14. adverse events.

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • History of persistent bronchial asthma for at least 6 months
  • FEV1 50-90% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
  • History of life-threatening asthma
  • Premature birth
  • Current smoking
  • Smoking history with either equal or more than 10 pack-years
  • 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): NCT00163410

Altana Pharma/Nycomed
Ahmedabad, India, 380 018
Altana Pharma/Nycomed
Bangalore, India, 560 034
Altana Pharma/Nycomed
Chandigarh, India, 160 012
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, India, 641 044
Altana Pharma/Nycomed
Coimbatore, India, 641 004
Altana Pharma/Nycomed
Coimbatore, India, 641 014
Altana Pharma/Nycomed
Delhi, India, 110 007
Altana Pharma/Nycomed
Kolkatta, India, 700091
Altana Pharma/Nycomed
Mumbai, India, 400 004
Altana Pharma/Nycomed
Mumbai, India, 400 012
Altana Pharma/Nycomed
Mumbai, India, 400 022
Altana Pharma/Nycomed
Mumbai, India, 400 026
Altana Pharma/Nycomed
Pune, India, 411 001
Altana Pharma/Nycomed
Pune, India, 411 030
Altana Pharma/Nycomed
Pune, India, 411 033
Altana Pharma/Nycomed
Shastri Nagar, Jaipur, India, 302 016
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00163410     History of Changes
Other Study ID Numbers: BY9010/M1-205
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 2, 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