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Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00163358
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
History of Changes
  Purpose

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • time until the first severe asthma exacerbation occurs
  • number of poorly controlled asthma days.

Secondary Outcome Measures:
  • percentage of days with asthma control
  • percentage of days with asthma symptoms
  • percentage of nocturnal awakenings due to asthma
  • asthma symptom score
  • number of inhalations of rescue medication
  • proportion of patients with severe asthma exacerbations
  • differences in morning PEF from diary
  • differences in FEV1 and FVC from spirometry
  • blood eosinophils
  • AQLQ(S)
  • health economic data
  • vital signs
  • laboratory work-up
  • adverse events.

Estimated Enrollment: 630
Study Start Date: September 2003
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Clinical diagnosis of mild persistent asthma
  • Pre-treatment with SABAs only
  • FEV1 ≥80% predicted
  • Good health with the exception of asthma

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 pulmonary function
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163358

  Show 111 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Chair: Paul O'Byrne, Prof. McMaster University in Hamilton, Ontario, Canada
Study Chair: Søren Pedersen, Prof. University of Odense, Kolding, Denmark
Study Chair: D.S. Postma, Prof. University Hospital of Groningen, The Netherlands
  More Information

No publications provided by Takeda Global Research & Development Center, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00163358     History of Changes
Other Study ID Numbers: BY9010/M1-132
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Takeda Global Research & Development Center, Inc.:
Asthma
Ciclesonide
Fluticasone propionate
Salmeterol

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Ciclesonide
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013