Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

Asthma Clinical Trial

Official title:

A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163410
• Other study ID #: BY9010/M1-205
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 1, 2016
• Start date: April 2003
• Est. completion date: December 2004

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: The Drug Controller General of Health Services
• Study type: Interventional

Clinical Trial 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 at one dose level once daily; 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
India	Altana Pharma/Nycomed	Ahmedabad
India	Altana Pharma/Nycomed	Bangalore
India	Altana Pharma/Nycomed	Chandigarh
India	Altana Pharma/Nycomed	Coimbatore
India	Altana Pharma/Nycomed	Coimbatore
India	Altana Pharma/Nycomed	Coimbatore, Tamilnadu
India	Altana Pharma/Nycomed	Delhi
India	Altana Pharma/Nycomed	Kolkatta
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Pune
India	Altana Pharma/Nycomed	Pune
India	Altana Pharma/Nycomed	Pune
India	Altana Pharma/Nycomed	Shastri Nagar, Jaipur

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 absolute values.
Secondary	FEV1 as % of predicted
Secondary	PEF from spirometry
Secondary	diary based morning and evening PEF
Secondary	diary based symptom score
Secondary	diary based salbutamol MDI use
Secondary	diurnal PEF fluctuation
Secondary	drop-out rate due to asthma exacerbations
Secondary	time until asthma exacerbation
Secondary	number of symptom free- and rescue medication free days
Secondary	number of days with asthma control
Secondary	physical examination
Secondary	vital signs
Secondary	laboratory work-up
Secondary	adverse events.

External Links

•   BY9010_M1-205 Synopsis