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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 12, 2005
Last updated: December 1, 2016
Last verified: December 2016
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 Intervention Phase
Asthma Drug: Ciclesonide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1 absolute values.

Secondary Outcome Measures:
  • FEV1 as % of predicted
  • PEF from spirometry
  • diary based morning and evening PEF
  • diary based symptom score
  • diary based salbutamol MDI use
  • diurnal PEF fluctuation
  • drop-out rate due to asthma exacerbations
  • time until asthma exacerbation
  • number of symptom free- and rescue medication free days
  • number of days with asthma control
  • physical examination
  • vital signs
  • laboratory work-up
  • adverse events.

Estimated Enrollment: 500
Study Start Date: April 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00163410     History of Changes
Other Study ID Numbers: BY9010/M1-205
Study First Received: September 12, 2005
Last Updated: December 1, 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 processed this record on August 18, 2017