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Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

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ClinicalTrials.gov Identifier: NCT00163319
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
Study Start Date : November 2004
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcome Measures :
  1. inhaled Corticosteroids Questionnaire (ICQ)
  2. proportion of cases of candidiasis of the oropharynx or
  3. hoarseness at each visit Secondary variables
  4. FEV1, FVC, PEF from spirometry
  5. morning and evening PEF from diaries
  6. diurnal PEF fluctuation
  7. onset of treatment effect
  8. percent days on which patient perceived asthma control
  9. percent of nocturnal awakening-free days
  10. percent of rescue medication free days
  11. percent symptom free days
  12. asthma symptom score
  13. use of rescue medication
  14. time to first asthma exacerbation
  15. number of patients with an asthma exacerbation
  16. AQLQ
  17. number of patients with candidiasis of the oropharynx or hoarseness by severity
  18. physical examination, ECG
  19. vital sings
  20. adverse events
  21. standard laboratory work-up
  22. morning serum cortisol
  23. skin bruising.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
  • FEV1 ≥ 80% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
  • COPD
  • Smoking with ≥10 pack-years
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception

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): NCT00163319


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163319     History of Changes
Other Study ID Numbers: BY9010/IT-101
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Asthma
Ciclesonide
Fluticasone propionate

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
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists