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
ClinicalTrials.gov Identifier:
NCT00163358
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 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:


Further study details as provided by Takeda:

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
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 ClinicalTrials.gov identifier: NCT00163358

  Show 111 Study Locations
Sponsors and Collaborators
Takeda
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

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:
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
Fluticasone
Salmeterol
Ciclesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids

ClinicalTrials.gov processed this record on September 16, 2014