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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

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ClinicalTrials.gov Identifier: NCT00163462
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 once daily, using one of the two dose levels; 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 or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
Study Start Date : October 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide




Primary Outcome Measures :
  1. FEV1 absolute values
  2. PD20FEV1 from methacholine challenge.

Secondary Outcome Measures :
  1. FEV1 as % of predicted
  2. PEF from spirometry
  3. morning and evening PEF from diary
  4. asthma symptom score from diary
  5. salbutamol MDI use from diary
  6. diurnal PEF fluctuation from diary
  7. dropout rate due to asthma exacerbations and time to the first asthma exacerbation
  8. percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
  9. onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
  10. interview administered PAQLQ(S), self-administered PACQLQ
  11. physical examination and vital signs
  12. laboratory investigation
  13. AEs
  14. HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT00163462


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163462    
Other Study ID Numbers: BY9010/M1-206
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents