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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)

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ClinicalTrials.gov Identifier: NCT00163358
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2003
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. percentage of days with asthma control
  2. percentage of days with asthma symptoms
  3. percentage of nocturnal awakenings due to asthma
  4. asthma symptom score
  5. number of inhalations of rescue medication
  6. proportion of patients with severe asthma exacerbations
  7. differences in morning PEF from diary
  8. differences in FEV1 and FVC from spirometry
  9. blood eosinophils
  10. AQLQ(S)
  11. health economic data
  12. vital signs
  13. laboratory work-up
  14. adverse events.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00163358


  Show 111 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163358     History of Changes
Other Study ID Numbers: BY9010/M1-132
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: October 2016

Keywords provided by AstraZeneca:
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 Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Ciclesonide
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones