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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT00163319
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
• Scientific title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
• Date of first enrolment: November 2004
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00163319
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, France, Italy, Netherlands, Spain, Switzerland, United Kingdom

Contacts

• Name: AstraZeneca AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Ciclesonide

Primary Outcome(s)

number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcome(s)

FEV1, FVC, PEF from spirometry

percent of nocturnal awakening-free days

percent of rescue medication free days

morning and evening PEF from diaries

morning serum cortisol

time to first asthma exacerbation

AQLQ

diurnal PEF fluctuation

percent days on which patient perceived asthma control

number of patients with an asthma exacerbation

proportion of cases of candidiasis of the oropharynx or

skin bruising.

hoarseness at each visit Secondary variables

onset of treatment effect

percent symptom free days

adverse events

number of patients with candidiasis of the oropharynx or hoarseness by severity

physical examination, ECG

use of rescue medication

asthma symptom score

inhaled Corticosteroids Questionnaire (ICQ)

standard laboratory work-up

vital sings

Secondary ID(s)

BY9010/IT-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors