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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163410
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Takeda:

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
  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163410

Locations
India
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, India, 641 014
Altana Pharma/Nycomed
Coimbatore, India, 641 004
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, India, 641 044
Altana Pharma/Nycomed
Delhi, India, 110 007
Altana Pharma/Nycomed
Kolkatta, India, 700091
Altana Pharma/Nycomed
Mumbai, India, 400 022
Altana Pharma/Nycomed
Mumbai, India, 400 004
Altana Pharma/Nycomed
Mumbai, India, 400 012
Altana Pharma/Nycomed
Mumbai, India, 400 026
Altana Pharma/Nycomed
Pune, India, 411 030
Altana Pharma/Nycomed
Pune, India, 411 033
Altana Pharma/Nycomed
Pune, India, 411 001
Altana Pharma/Nycomed
Shastri Nagar, Jaipur, India, 302 016
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Renate Engelstaetter, PhD ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163410     History of Changes
Other Study ID Numbers: BY9010/M1-205
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: India: The Drug Controller General of Health Services

Keywords provided by Takeda:
Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014